The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond
Abstract Prescription medication abuse, particularly of opioids, remains a serious public health problem. Many socioeconomic and healthcare system factors have contributed to the resulting epidemic of prescription opioid abuse. As the scope of this epidemic became evident, efforts to make abuse-dete...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Sellers, Edward M. [verfasserIn] |
|---|
| Format: |
E-Artikel |
|---|---|
| Sprache: |
Englisch |
| Erschienen: |
2014 |
|---|
| Schlagwörter: |
|---|
| Anmerkung: |
© Springer International Publishing Switzerland 2014 |
|---|
| Übergeordnetes Werk: |
Enthalten in: Pharmaceutical medicine - Auckland : Wolters Kluwer Health Adis, 2008, 28(2014), 6 vom: 08. Okt., Seite 317-327 |
|---|---|
| Übergeordnetes Werk: |
volume:28 ; year:2014 ; number:6 ; day:08 ; month:10 ; pages:317-327 |
| Links: |
|---|
| DOI / URN: |
10.1007/s40290-014-0067-1 |
|---|
| Katalog-ID: |
SPR035366273 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | SPR035366273 | ||
| 003 | DE-627 | ||
| 005 | 20230519114429.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 201007s2014 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s40290-014-0067-1 |2 doi | |
| 035 | |a (DE-627)SPR035366273 | ||
| 035 | |a (SPR)s40290-014-0067-1-e | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Sellers, Edward M. |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond |
| 264 | 1 | |c 2014 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a © Springer International Publishing Switzerland 2014 | ||
| 520 | |a Abstract Prescription medication abuse, particularly of opioids, remains a serious public health problem. Many socioeconomic and healthcare system factors have contributed to the resulting epidemic of prescription opioid abuse. As the scope of this epidemic became evident, efforts to make abuse-deterrent formulations (ADFs) began, and many ADFs are under development. In January 2013, the US Food and Drug Administration (FDA) issued a Draft Guidance outlining the categories of studies needed for evaluating the abuse-deterrent properties of ADF opioids (e.g., pre-market in vitro, pharmacokinetic and abuse potential studies, and post-marketing studies) and the four potential label claims that might be made about the products. Studies to be conducted are those required for approval, those that might be included as data in the label (implicit claims), and those that would be required to merit a specific explicit claim—Tier 1, 2, 3, or 4. In the context of the Guidance, new ADFs need to consider the unique features of their technology, market size, comparator products, actual routes and methods of abuse, the targeted health consequences of abuse, pricing and reimbursement, the impact of other interventions to decrease abuse, and the challenges in doing post-market studies. ADFs will not stop prescription opioid drug abuse; however, easily tampered formulations should not contribute to the problem. All extended-release (ER) opioids and other abusable drugs should have abuse-deterrent properties. Immediate-release (IR) opioids should also be formulated with abuse-deterrent properties, because abuse of IR opioids is a more common and serious problem than that of ER opioids. Maximum dosage strengths of ER opioids should also be limited. Finally, the current situation, where non-abuse-deterrent ER opioids exist concurrently on the market is extremely problematic from a public health policy perspective. | ||
| 650 | 4 | |a Draft Guidance |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a OxyContin |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Prescription Drug Abuse |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Prescription Opioid Abuse |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Opana |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Shram, Megan J. |4 aut | |
| 700 | 1 | |a Schoedel, Kerri A. |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Pharmaceutical medicine |d Auckland : Wolters Kluwer Health Adis, 2008 |g 28(2014), 6 vom: 08. Okt., Seite 317-327 |w (DE-627)56017375X |w (DE-600)2415180-4 |x 1179-1993 |7 nnns |
| 773 | 1 | 8 | |g volume:28 |g year:2014 |g number:6 |g day:08 |g month:10 |g pages:317-327 |
| 856 | 4 | 0 | |u https://dx.doi.org/10.1007/s40290-014-0067-1 |z lizenzpflichtig |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a SYSFLAG_A | ||
| 912 | |a GBV_SPRINGER | ||
| 912 | |a SSG-OLC-PHA | ||
| 912 | |a GBV_ILN_11 | ||
| 912 | |a GBV_ILN_20 | ||
| 912 | |a GBV_ILN_22 | ||
| 912 | |a GBV_ILN_23 | ||
| 912 | |a GBV_ILN_24 | ||
| 912 | |a GBV_ILN_31 | ||
| 912 | |a GBV_ILN_32 | ||
| 912 | |a GBV_ILN_39 | ||
| 912 | |a GBV_ILN_40 | ||
| 912 | |a GBV_ILN_60 | ||
| 912 | |a GBV_ILN_62 | ||
| 912 | |a GBV_ILN_63 | ||
| 912 | |a GBV_ILN_65 | ||
| 912 | |a GBV_ILN_69 | ||
| 912 | |a GBV_ILN_70 | ||
| 912 | |a GBV_ILN_73 | ||
| 912 | |a GBV_ILN_74 | ||
| 912 | |a GBV_ILN_90 | ||
| 912 | |a GBV_ILN_95 | ||
| 912 | |a GBV_ILN_100 | ||
| 912 | |a GBV_ILN_101 | ||
| 912 | |a GBV_ILN_105 | ||
| 912 | |a GBV_ILN_110 | ||
| 912 | |a GBV_ILN_120 | ||
| 912 | |a GBV_ILN_138 | ||
| 912 | |a GBV_ILN_150 | ||
| 912 | |a GBV_ILN_151 | ||
| 912 | |a GBV_ILN_161 | ||
| 912 | |a GBV_ILN_170 | ||
| 912 | |a GBV_ILN_171 | ||
| 912 | |a GBV_ILN_187 | ||
| 912 | |a GBV_ILN_206 | ||
| 912 | |a GBV_ILN_213 | ||
| 912 | |a GBV_ILN_224 | ||
| 912 | |a GBV_ILN_230 | ||
| 912 | |a GBV_ILN_250 | ||
| 912 | |a GBV_ILN_266 | ||
| 912 | |a GBV_ILN_281 | ||
| 912 | |a GBV_ILN_285 | ||
| 912 | |a GBV_ILN_293 | ||
| 912 | |a GBV_ILN_370 | ||
| 912 | |a GBV_ILN_602 | ||
| 912 | |a GBV_ILN_636 | ||
| 912 | |a GBV_ILN_702 | ||
| 912 | |a GBV_ILN_2001 | ||
| 912 | |a GBV_ILN_2003 | ||
| 912 | |a GBV_ILN_2004 | ||
| 912 | |a GBV_ILN_2005 | ||
| 912 | |a GBV_ILN_2006 | ||
| 912 | |a GBV_ILN_2007 | ||
| 912 | |a GBV_ILN_2008 | ||
| 912 | |a GBV_ILN_2009 | ||
| 912 | |a GBV_ILN_2010 | ||
| 912 | |a GBV_ILN_2011 | ||
| 912 | |a GBV_ILN_2014 | ||
| 912 | |a GBV_ILN_2015 | ||
| 912 | |a GBV_ILN_2020 | ||
| 912 | |a GBV_ILN_2021 | ||
| 912 | |a GBV_ILN_2025 | ||
| 912 | |a GBV_ILN_2026 | ||
| 912 | |a GBV_ILN_2027 | ||
| 912 | |a GBV_ILN_2031 | ||
| 912 | |a GBV_ILN_2034 | ||
| 912 | |a GBV_ILN_2037 | ||
| 912 | |a GBV_ILN_2038 | ||
| 912 | |a GBV_ILN_2039 | ||
| 912 | |a GBV_ILN_2044 | ||
| 912 | |a GBV_ILN_2048 | ||
| 912 | |a GBV_ILN_2049 | ||
| 912 | |a GBV_ILN_2050 | ||
| 912 | |a GBV_ILN_2055 | ||
| 912 | |a GBV_ILN_2057 | ||
| 912 | |a GBV_ILN_2059 | ||
| 912 | |a GBV_ILN_2061 | ||
| 912 | |a GBV_ILN_2064 | ||
| 912 | |a GBV_ILN_2065 | ||
| 912 | |a GBV_ILN_2068 | ||
| 912 | |a GBV_ILN_2088 | ||
| 912 | |a GBV_ILN_2093 | ||
| 912 | |a GBV_ILN_2106 | ||
| 912 | |a GBV_ILN_2107 | ||
| 912 | |a GBV_ILN_2108 | ||
| 912 | |a GBV_ILN_2110 | ||
| 912 | |a GBV_ILN_2111 | ||
| 912 | |a GBV_ILN_2112 | ||
| 912 | |a GBV_ILN_2113 | ||
| 912 | |a GBV_ILN_2118 | ||
| 912 | |a GBV_ILN_2129 | ||
| 912 | |a GBV_ILN_2143 | ||
| 912 | |a GBV_ILN_2144 | ||
| 912 | |a GBV_ILN_2147 | ||
| 912 | |a GBV_ILN_2148 | ||
| 912 | |a GBV_ILN_2152 | ||
| 912 | |a GBV_ILN_2153 | ||
| 912 | |a GBV_ILN_2188 | ||
| 912 | |a GBV_ILN_2190 | ||
| 912 | |a GBV_ILN_2232 | ||
| 912 | |a GBV_ILN_2336 | ||
| 912 | |a GBV_ILN_2446 | ||
| 912 | |a GBV_ILN_2470 | ||
| 912 | |a GBV_ILN_2507 | ||
| 912 | |a GBV_ILN_2522 | ||
| 912 | |a GBV_ILN_2548 | ||
| 912 | |a GBV_ILN_4035 | ||
| 912 | |a GBV_ILN_4037 | ||
| 912 | |a GBV_ILN_4046 | ||
| 912 | |a GBV_ILN_4112 | ||
| 912 | |a GBV_ILN_4125 | ||
| 912 | |a GBV_ILN_4242 | ||
| 912 | |a GBV_ILN_4246 | ||
| 912 | |a GBV_ILN_4249 | ||
| 912 | |a GBV_ILN_4251 | ||
| 912 | |a GBV_ILN_4305 | ||
| 912 | |a GBV_ILN_4306 | ||
| 912 | |a GBV_ILN_4307 | ||
| 912 | |a GBV_ILN_4313 | ||
| 912 | |a GBV_ILN_4322 | ||
| 912 | |a GBV_ILN_4323 | ||
| 912 | |a GBV_ILN_4324 | ||
| 912 | |a GBV_ILN_4325 | ||
| 912 | |a GBV_ILN_4326 | ||
| 912 | |a GBV_ILN_4333 | ||
| 912 | |a GBV_ILN_4334 | ||
| 912 | |a GBV_ILN_4335 | ||
| 912 | |a GBV_ILN_4336 | ||
| 912 | |a GBV_ILN_4338 | ||
| 912 | |a GBV_ILN_4393 | ||
| 912 | |a GBV_ILN_4700 | ||
| 951 | |a AR | ||
| 952 | |d 28 |j 2014 |e 6 |b 08 |c 10 |h 317-327 | ||
| author_variant |
e m s em ems m j s mj mjs k a s ka kas |
|---|---|
| matchkey_str |
article:11791993:2014----::hufarfgiacfreeoigbsdtretpodn |
| hierarchy_sort_str |
2014 |
| publishDate |
2014 |
| allfields |
10.1007/s40290-014-0067-1 doi (DE-627)SPR035366273 (SPR)s40290-014-0067-1-e DE-627 ger DE-627 rakwb eng Sellers, Edward M. verfasserin aut The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer International Publishing Switzerland 2014 Abstract Prescription medication abuse, particularly of opioids, remains a serious public health problem. Many socioeconomic and healthcare system factors have contributed to the resulting epidemic of prescription opioid abuse. As the scope of this epidemic became evident, efforts to make abuse-deterrent formulations (ADFs) began, and many ADFs are under development. In January 2013, the US Food and Drug Administration (FDA) issued a Draft Guidance outlining the categories of studies needed for evaluating the abuse-deterrent properties of ADF opioids (e.g., pre-market in vitro, pharmacokinetic and abuse potential studies, and post-marketing studies) and the four potential label claims that might be made about the products. Studies to be conducted are those required for approval, those that might be included as data in the label (implicit claims), and those that would be required to merit a specific explicit claim—Tier 1, 2, 3, or 4. In the context of the Guidance, new ADFs need to consider the unique features of their technology, market size, comparator products, actual routes and methods of abuse, the targeted health consequences of abuse, pricing and reimbursement, the impact of other interventions to decrease abuse, and the challenges in doing post-market studies. ADFs will not stop prescription opioid drug abuse; however, easily tampered formulations should not contribute to the problem. All extended-release (ER) opioids and other abusable drugs should have abuse-deterrent properties. Immediate-release (IR) opioids should also be formulated with abuse-deterrent properties, because abuse of IR opioids is a more common and serious problem than that of ER opioids. Maximum dosage strengths of ER opioids should also be limited. Finally, the current situation, where non-abuse-deterrent ER opioids exist concurrently on the market is extremely problematic from a public health policy perspective. Draft Guidance (dpeaa)DE-He213 OxyContin (dpeaa)DE-He213 Prescription Drug Abuse (dpeaa)DE-He213 Prescription Opioid Abuse (dpeaa)DE-He213 Opana (dpeaa)DE-He213 Shram, Megan J. aut Schoedel, Kerri A. aut Enthalten in Pharmaceutical medicine Auckland : Wolters Kluwer Health Adis, 2008 28(2014), 6 vom: 08. Okt., Seite 317-327 (DE-627)56017375X (DE-600)2415180-4 1179-1993 nnns volume:28 year:2014 number:6 day:08 month:10 pages:317-327 https://dx.doi.org/10.1007/s40290-014-0067-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 28 2014 6 08 10 317-327 |
| spelling |
10.1007/s40290-014-0067-1 doi (DE-627)SPR035366273 (SPR)s40290-014-0067-1-e DE-627 ger DE-627 rakwb eng Sellers, Edward M. verfasserin aut The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer International Publishing Switzerland 2014 Abstract Prescription medication abuse, particularly of opioids, remains a serious public health problem. Many socioeconomic and healthcare system factors have contributed to the resulting epidemic of prescription opioid abuse. As the scope of this epidemic became evident, efforts to make abuse-deterrent formulations (ADFs) began, and many ADFs are under development. In January 2013, the US Food and Drug Administration (FDA) issued a Draft Guidance outlining the categories of studies needed for evaluating the abuse-deterrent properties of ADF opioids (e.g., pre-market in vitro, pharmacokinetic and abuse potential studies, and post-marketing studies) and the four potential label claims that might be made about the products. Studies to be conducted are those required for approval, those that might be included as data in the label (implicit claims), and those that would be required to merit a specific explicit claim—Tier 1, 2, 3, or 4. In the context of the Guidance, new ADFs need to consider the unique features of their technology, market size, comparator products, actual routes and methods of abuse, the targeted health consequences of abuse, pricing and reimbursement, the impact of other interventions to decrease abuse, and the challenges in doing post-market studies. ADFs will not stop prescription opioid drug abuse; however, easily tampered formulations should not contribute to the problem. All extended-release (ER) opioids and other abusable drugs should have abuse-deterrent properties. Immediate-release (IR) opioids should also be formulated with abuse-deterrent properties, because abuse of IR opioids is a more common and serious problem than that of ER opioids. Maximum dosage strengths of ER opioids should also be limited. Finally, the current situation, where non-abuse-deterrent ER opioids exist concurrently on the market is extremely problematic from a public health policy perspective. Draft Guidance (dpeaa)DE-He213 OxyContin (dpeaa)DE-He213 Prescription Drug Abuse (dpeaa)DE-He213 Prescription Opioid Abuse (dpeaa)DE-He213 Opana (dpeaa)DE-He213 Shram, Megan J. aut Schoedel, Kerri A. aut Enthalten in Pharmaceutical medicine Auckland : Wolters Kluwer Health Adis, 2008 28(2014), 6 vom: 08. Okt., Seite 317-327 (DE-627)56017375X (DE-600)2415180-4 1179-1993 nnns volume:28 year:2014 number:6 day:08 month:10 pages:317-327 https://dx.doi.org/10.1007/s40290-014-0067-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 28 2014 6 08 10 317-327 |
| allfields_unstemmed |
10.1007/s40290-014-0067-1 doi (DE-627)SPR035366273 (SPR)s40290-014-0067-1-e DE-627 ger DE-627 rakwb eng Sellers, Edward M. verfasserin aut The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer International Publishing Switzerland 2014 Abstract Prescription medication abuse, particularly of opioids, remains a serious public health problem. Many socioeconomic and healthcare system factors have contributed to the resulting epidemic of prescription opioid abuse. As the scope of this epidemic became evident, efforts to make abuse-deterrent formulations (ADFs) began, and many ADFs are under development. In January 2013, the US Food and Drug Administration (FDA) issued a Draft Guidance outlining the categories of studies needed for evaluating the abuse-deterrent properties of ADF opioids (e.g., pre-market in vitro, pharmacokinetic and abuse potential studies, and post-marketing studies) and the four potential label claims that might be made about the products. Studies to be conducted are those required for approval, those that might be included as data in the label (implicit claims), and those that would be required to merit a specific explicit claim—Tier 1, 2, 3, or 4. In the context of the Guidance, new ADFs need to consider the unique features of their technology, market size, comparator products, actual routes and methods of abuse, the targeted health consequences of abuse, pricing and reimbursement, the impact of other interventions to decrease abuse, and the challenges in doing post-market studies. ADFs will not stop prescription opioid drug abuse; however, easily tampered formulations should not contribute to the problem. All extended-release (ER) opioids and other abusable drugs should have abuse-deterrent properties. Immediate-release (IR) opioids should also be formulated with abuse-deterrent properties, because abuse of IR opioids is a more common and serious problem than that of ER opioids. Maximum dosage strengths of ER opioids should also be limited. Finally, the current situation, where non-abuse-deterrent ER opioids exist concurrently on the market is extremely problematic from a public health policy perspective. Draft Guidance (dpeaa)DE-He213 OxyContin (dpeaa)DE-He213 Prescription Drug Abuse (dpeaa)DE-He213 Prescription Opioid Abuse (dpeaa)DE-He213 Opana (dpeaa)DE-He213 Shram, Megan J. aut Schoedel, Kerri A. aut Enthalten in Pharmaceutical medicine Auckland : Wolters Kluwer Health Adis, 2008 28(2014), 6 vom: 08. Okt., Seite 317-327 (DE-627)56017375X (DE-600)2415180-4 1179-1993 nnns volume:28 year:2014 number:6 day:08 month:10 pages:317-327 https://dx.doi.org/10.1007/s40290-014-0067-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 28 2014 6 08 10 317-327 |
| allfieldsGer |
10.1007/s40290-014-0067-1 doi (DE-627)SPR035366273 (SPR)s40290-014-0067-1-e DE-627 ger DE-627 rakwb eng Sellers, Edward M. verfasserin aut The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer International Publishing Switzerland 2014 Abstract Prescription medication abuse, particularly of opioids, remains a serious public health problem. Many socioeconomic and healthcare system factors have contributed to the resulting epidemic of prescription opioid abuse. As the scope of this epidemic became evident, efforts to make abuse-deterrent formulations (ADFs) began, and many ADFs are under development. In January 2013, the US Food and Drug Administration (FDA) issued a Draft Guidance outlining the categories of studies needed for evaluating the abuse-deterrent properties of ADF opioids (e.g., pre-market in vitro, pharmacokinetic and abuse potential studies, and post-marketing studies) and the four potential label claims that might be made about the products. Studies to be conducted are those required for approval, those that might be included as data in the label (implicit claims), and those that would be required to merit a specific explicit claim—Tier 1, 2, 3, or 4. In the context of the Guidance, new ADFs need to consider the unique features of their technology, market size, comparator products, actual routes and methods of abuse, the targeted health consequences of abuse, pricing and reimbursement, the impact of other interventions to decrease abuse, and the challenges in doing post-market studies. ADFs will not stop prescription opioid drug abuse; however, easily tampered formulations should not contribute to the problem. All extended-release (ER) opioids and other abusable drugs should have abuse-deterrent properties. Immediate-release (IR) opioids should also be formulated with abuse-deterrent properties, because abuse of IR opioids is a more common and serious problem than that of ER opioids. Maximum dosage strengths of ER opioids should also be limited. Finally, the current situation, where non-abuse-deterrent ER opioids exist concurrently on the market is extremely problematic from a public health policy perspective. Draft Guidance (dpeaa)DE-He213 OxyContin (dpeaa)DE-He213 Prescription Drug Abuse (dpeaa)DE-He213 Prescription Opioid Abuse (dpeaa)DE-He213 Opana (dpeaa)DE-He213 Shram, Megan J. aut Schoedel, Kerri A. aut Enthalten in Pharmaceutical medicine Auckland : Wolters Kluwer Health Adis, 2008 28(2014), 6 vom: 08. Okt., Seite 317-327 (DE-627)56017375X (DE-600)2415180-4 1179-1993 nnns volume:28 year:2014 number:6 day:08 month:10 pages:317-327 https://dx.doi.org/10.1007/s40290-014-0067-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 28 2014 6 08 10 317-327 |
| allfieldsSound |
10.1007/s40290-014-0067-1 doi (DE-627)SPR035366273 (SPR)s40290-014-0067-1-e DE-627 ger DE-627 rakwb eng Sellers, Edward M. verfasserin aut The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer International Publishing Switzerland 2014 Abstract Prescription medication abuse, particularly of opioids, remains a serious public health problem. Many socioeconomic and healthcare system factors have contributed to the resulting epidemic of prescription opioid abuse. As the scope of this epidemic became evident, efforts to make abuse-deterrent formulations (ADFs) began, and many ADFs are under development. In January 2013, the US Food and Drug Administration (FDA) issued a Draft Guidance outlining the categories of studies needed for evaluating the abuse-deterrent properties of ADF opioids (e.g., pre-market in vitro, pharmacokinetic and abuse potential studies, and post-marketing studies) and the four potential label claims that might be made about the products. Studies to be conducted are those required for approval, those that might be included as data in the label (implicit claims), and those that would be required to merit a specific explicit claim—Tier 1, 2, 3, or 4. In the context of the Guidance, new ADFs need to consider the unique features of their technology, market size, comparator products, actual routes and methods of abuse, the targeted health consequences of abuse, pricing and reimbursement, the impact of other interventions to decrease abuse, and the challenges in doing post-market studies. ADFs will not stop prescription opioid drug abuse; however, easily tampered formulations should not contribute to the problem. All extended-release (ER) opioids and other abusable drugs should have abuse-deterrent properties. Immediate-release (IR) opioids should also be formulated with abuse-deterrent properties, because abuse of IR opioids is a more common and serious problem than that of ER opioids. Maximum dosage strengths of ER opioids should also be limited. Finally, the current situation, where non-abuse-deterrent ER opioids exist concurrently on the market is extremely problematic from a public health policy perspective. Draft Guidance (dpeaa)DE-He213 OxyContin (dpeaa)DE-He213 Prescription Drug Abuse (dpeaa)DE-He213 Prescription Opioid Abuse (dpeaa)DE-He213 Opana (dpeaa)DE-He213 Shram, Megan J. aut Schoedel, Kerri A. aut Enthalten in Pharmaceutical medicine Auckland : Wolters Kluwer Health Adis, 2008 28(2014), 6 vom: 08. Okt., Seite 317-327 (DE-627)56017375X (DE-600)2415180-4 1179-1993 nnns volume:28 year:2014 number:6 day:08 month:10 pages:317-327 https://dx.doi.org/10.1007/s40290-014-0067-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 28 2014 6 08 10 317-327 |
| language |
English |
| source |
Enthalten in Pharmaceutical medicine 28(2014), 6 vom: 08. Okt., Seite 317-327 volume:28 year:2014 number:6 day:08 month:10 pages:317-327 |
| sourceStr |
Enthalten in Pharmaceutical medicine 28(2014), 6 vom: 08. Okt., Seite 317-327 volume:28 year:2014 number:6 day:08 month:10 pages:317-327 |
| format_phy_str_mv |
Article |
| institution |
findex.gbv.de |
| topic_facet |
Draft Guidance OxyContin Prescription Drug Abuse Prescription Opioid Abuse Opana |
| isfreeaccess_bool |
false |
| container_title |
Pharmaceutical medicine |
| authorswithroles_txt_mv |
Sellers, Edward M. @@aut@@ Shram, Megan J. @@aut@@ Schoedel, Kerri A. @@aut@@ |
| publishDateDaySort_date |
2014-10-08T00:00:00Z |
| hierarchy_top_id |
56017375X |
| id |
SPR035366273 |
| language_de |
englisch |
| fullrecord |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR035366273</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519114429.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2014 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1007/s40290-014-0067-1</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR035366273</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s40290-014-0067-1-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Sellers, Edward M.</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="4"><subfield code="a">The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2014</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© Springer International Publishing Switzerland 2014</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Abstract Prescription medication abuse, particularly of opioids, remains a serious public health problem. Many socioeconomic and healthcare system factors have contributed to the resulting epidemic of prescription opioid abuse. As the scope of this epidemic became evident, efforts to make abuse-deterrent formulations (ADFs) began, and many ADFs are under development. In January 2013, the US Food and Drug Administration (FDA) issued a Draft Guidance outlining the categories of studies needed for evaluating the abuse-deterrent properties of ADF opioids (e.g., pre-market in vitro, pharmacokinetic and abuse potential studies, and post-marketing studies) and the four potential label claims that might be made about the products. Studies to be conducted are those required for approval, those that might be included as data in the label (implicit claims), and those that would be required to merit a specific explicit claim—Tier 1, 2, 3, or 4. In the context of the Guidance, new ADFs need to consider the unique features of their technology, market size, comparator products, actual routes and methods of abuse, the targeted health consequences of abuse, pricing and reimbursement, the impact of other interventions to decrease abuse, and the challenges in doing post-market studies. ADFs will not stop prescription opioid drug abuse; however, easily tampered formulations should not contribute to the problem. All extended-release (ER) opioids and other abusable drugs should have abuse-deterrent properties. Immediate-release (IR) opioids should also be formulated with abuse-deterrent properties, because abuse of IR opioids is a more common and serious problem than that of ER opioids. Maximum dosage strengths of ER opioids should also be limited. Finally, the current situation, where non-abuse-deterrent ER opioids exist concurrently on the market is extremely problematic from a public health policy perspective.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Draft Guidance</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">OxyContin</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Prescription Drug Abuse</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Prescription Opioid Abuse</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Opana</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Shram, Megan J.</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Schoedel, Kerri A.</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">Pharmaceutical medicine</subfield><subfield code="d">Auckland : Wolters Kluwer Health Adis, 2008</subfield><subfield code="g">28(2014), 6 vom: 08. Okt., Seite 317-327</subfield><subfield code="w">(DE-627)56017375X</subfield><subfield code="w">(DE-600)2415180-4</subfield><subfield code="x">1179-1993</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:28</subfield><subfield code="g">year:2014</subfield><subfield code="g">number:6</subfield><subfield code="g">day:08</subfield><subfield code="g">month:10</subfield><subfield code="g">pages:317-327</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://dx.doi.org/10.1007/s40290-014-0067-1</subfield><subfield code="z">lizenzpflichtig</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_SPRINGER</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SSG-OLC-PHA</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_11</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_20</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_22</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_23</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_24</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_31</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_32</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_39</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_40</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_60</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_62</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_63</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_65</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_69</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_70</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_73</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_74</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_90</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_95</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_100</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_101</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_105</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_120</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_138</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_150</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_151</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_161</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_170</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_171</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_187</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_206</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_213</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_224</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_230</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_250</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_266</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_281</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_285</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_293</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_370</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_602</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_636</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_702</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2001</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2003</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2004</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2005</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2006</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2007</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2008</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2009</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2010</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2011</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2014</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2015</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2020</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2021</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2025</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2026</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2027</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2031</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2034</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2037</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2038</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2039</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2044</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2048</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2049</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2050</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2055</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2057</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2059</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2061</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2064</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2065</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2068</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2088</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2093</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2106</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2107</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2108</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2111</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2112</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2113</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2118</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2129</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2143</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2144</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2147</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2148</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2152</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2153</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2188</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2190</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2232</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2336</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2446</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2470</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2507</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2522</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2548</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4035</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4037</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4046</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4112</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4125</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4242</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4246</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4249</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4251</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4305</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4306</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4307</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4313</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4322</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4323</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4324</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4325</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4326</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4333</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4334</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4335</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4336</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4338</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4393</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4700</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">28</subfield><subfield code="j">2014</subfield><subfield code="e">6</subfield><subfield code="b">08</subfield><subfield code="c">10</subfield><subfield code="h">317-327</subfield></datafield></record></collection>
|
| author |
Sellers, Edward M. |
| spellingShingle |
Sellers, Edward M. misc Draft Guidance misc OxyContin misc Prescription Drug Abuse misc Prescription Opioid Abuse misc Opana The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond |
| authorStr |
Sellers, Edward M. |
| ppnlink_with_tag_str_mv |
@@773@@(DE-627)56017375X |
| format |
electronic Article |
| delete_txt_mv |
keep |
| author_role |
aut aut aut |
| collection |
springer |
| remote_str |
true |
| illustrated |
Not Illustrated |
| issn |
1179-1993 |
| topic_title |
The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond Draft Guidance (dpeaa)DE-He213 OxyContin (dpeaa)DE-He213 Prescription Drug Abuse (dpeaa)DE-He213 Prescription Opioid Abuse (dpeaa)DE-He213 Opana (dpeaa)DE-He213 |
| topic |
misc Draft Guidance misc OxyContin misc Prescription Drug Abuse misc Prescription Opioid Abuse misc Opana |
| topic_unstemmed |
misc Draft Guidance misc OxyContin misc Prescription Drug Abuse misc Prescription Opioid Abuse misc Opana |
| topic_browse |
misc Draft Guidance misc OxyContin misc Prescription Drug Abuse misc Prescription Opioid Abuse misc Opana |
| format_facet |
Elektronische Aufsätze Aufsätze Elektronische Ressource |
| format_main_str_mv |
Text Zeitschrift/Artikel |
| carriertype_str_mv |
cr |
| hierarchy_parent_title |
Pharmaceutical medicine |
| hierarchy_parent_id |
56017375X |
| hierarchy_top_title |
Pharmaceutical medicine |
| isfreeaccess_txt |
false |
| familylinks_str_mv |
(DE-627)56017375X (DE-600)2415180-4 |
| title |
The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond |
| ctrlnum |
(DE-627)SPR035366273 (SPR)s40290-014-0067-1-e |
| title_full |
The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond |
| author_sort |
Sellers, Edward M. |
| journal |
Pharmaceutical medicine |
| journalStr |
Pharmaceutical medicine |
| lang_code |
eng |
| isOA_bool |
false |
| recordtype |
marc |
| publishDateSort |
2014 |
| contenttype_str_mv |
txt |
| container_start_page |
317 |
| author_browse |
Sellers, Edward M. Shram, Megan J. Schoedel, Kerri A. |
| container_volume |
28 |
| format_se |
Elektronische Aufsätze |
| author-letter |
Sellers, Edward M. |
| doi_str_mv |
10.1007/s40290-014-0067-1 |
| title_sort |
us fda draft guidance for developing abuse-deterrent opioid analgesics: 2014 and beyond |
| title_auth |
The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond |
| abstract |
Abstract Prescription medication abuse, particularly of opioids, remains a serious public health problem. Many socioeconomic and healthcare system factors have contributed to the resulting epidemic of prescription opioid abuse. As the scope of this epidemic became evident, efforts to make abuse-deterrent formulations (ADFs) began, and many ADFs are under development. In January 2013, the US Food and Drug Administration (FDA) issued a Draft Guidance outlining the categories of studies needed for evaluating the abuse-deterrent properties of ADF opioids (e.g., pre-market in vitro, pharmacokinetic and abuse potential studies, and post-marketing studies) and the four potential label claims that might be made about the products. Studies to be conducted are those required for approval, those that might be included as data in the label (implicit claims), and those that would be required to merit a specific explicit claim—Tier 1, 2, 3, or 4. In the context of the Guidance, new ADFs need to consider the unique features of their technology, market size, comparator products, actual routes and methods of abuse, the targeted health consequences of abuse, pricing and reimbursement, the impact of other interventions to decrease abuse, and the challenges in doing post-market studies. ADFs will not stop prescription opioid drug abuse; however, easily tampered formulations should not contribute to the problem. All extended-release (ER) opioids and other abusable drugs should have abuse-deterrent properties. Immediate-release (IR) opioids should also be formulated with abuse-deterrent properties, because abuse of IR opioids is a more common and serious problem than that of ER opioids. Maximum dosage strengths of ER opioids should also be limited. Finally, the current situation, where non-abuse-deterrent ER opioids exist concurrently on the market is extremely problematic from a public health policy perspective. © Springer International Publishing Switzerland 2014 |
| abstractGer |
Abstract Prescription medication abuse, particularly of opioids, remains a serious public health problem. Many socioeconomic and healthcare system factors have contributed to the resulting epidemic of prescription opioid abuse. As the scope of this epidemic became evident, efforts to make abuse-deterrent formulations (ADFs) began, and many ADFs are under development. In January 2013, the US Food and Drug Administration (FDA) issued a Draft Guidance outlining the categories of studies needed for evaluating the abuse-deterrent properties of ADF opioids (e.g., pre-market in vitro, pharmacokinetic and abuse potential studies, and post-marketing studies) and the four potential label claims that might be made about the products. Studies to be conducted are those required for approval, those that might be included as data in the label (implicit claims), and those that would be required to merit a specific explicit claim—Tier 1, 2, 3, or 4. In the context of the Guidance, new ADFs need to consider the unique features of their technology, market size, comparator products, actual routes and methods of abuse, the targeted health consequences of abuse, pricing and reimbursement, the impact of other interventions to decrease abuse, and the challenges in doing post-market studies. ADFs will not stop prescription opioid drug abuse; however, easily tampered formulations should not contribute to the problem. All extended-release (ER) opioids and other abusable drugs should have abuse-deterrent properties. Immediate-release (IR) opioids should also be formulated with abuse-deterrent properties, because abuse of IR opioids is a more common and serious problem than that of ER opioids. Maximum dosage strengths of ER opioids should also be limited. Finally, the current situation, where non-abuse-deterrent ER opioids exist concurrently on the market is extremely problematic from a public health policy perspective. © Springer International Publishing Switzerland 2014 |
| abstract_unstemmed |
Abstract Prescription medication abuse, particularly of opioids, remains a serious public health problem. Many socioeconomic and healthcare system factors have contributed to the resulting epidemic of prescription opioid abuse. As the scope of this epidemic became evident, efforts to make abuse-deterrent formulations (ADFs) began, and many ADFs are under development. In January 2013, the US Food and Drug Administration (FDA) issued a Draft Guidance outlining the categories of studies needed for evaluating the abuse-deterrent properties of ADF opioids (e.g., pre-market in vitro, pharmacokinetic and abuse potential studies, and post-marketing studies) and the four potential label claims that might be made about the products. Studies to be conducted are those required for approval, those that might be included as data in the label (implicit claims), and those that would be required to merit a specific explicit claim—Tier 1, 2, 3, or 4. In the context of the Guidance, new ADFs need to consider the unique features of their technology, market size, comparator products, actual routes and methods of abuse, the targeted health consequences of abuse, pricing and reimbursement, the impact of other interventions to decrease abuse, and the challenges in doing post-market studies. ADFs will not stop prescription opioid drug abuse; however, easily tampered formulations should not contribute to the problem. All extended-release (ER) opioids and other abusable drugs should have abuse-deterrent properties. Immediate-release (IR) opioids should also be formulated with abuse-deterrent properties, because abuse of IR opioids is a more common and serious problem than that of ER opioids. Maximum dosage strengths of ER opioids should also be limited. Finally, the current situation, where non-abuse-deterrent ER opioids exist concurrently on the market is extremely problematic from a public health policy perspective. © Springer International Publishing Switzerland 2014 |
| collection_details |
GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 |
| container_issue |
6 |
| title_short |
The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond |
| url |
https://dx.doi.org/10.1007/s40290-014-0067-1 |
| remote_bool |
true |
| author2 |
Shram, Megan J. Schoedel, Kerri A. |
| author2Str |
Shram, Megan J. Schoedel, Kerri A. |
| ppnlink |
56017375X |
| mediatype_str_mv |
c |
| isOA_txt |
false |
| hochschulschrift_bool |
false |
| doi_str |
10.1007/s40290-014-0067-1 |
| up_date |
2024-07-03T14:16:04.102Z |
| _version_ |
1803567669298855936 |
| fullrecord_marcxml |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR035366273</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519114429.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2014 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1007/s40290-014-0067-1</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR035366273</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s40290-014-0067-1-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Sellers, Edward M.</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="4"><subfield code="a">The US FDA Draft Guidance for Developing Abuse-Deterrent Opioid Analgesics: 2014 and Beyond</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2014</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© Springer International Publishing Switzerland 2014</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Abstract Prescription medication abuse, particularly of opioids, remains a serious public health problem. Many socioeconomic and healthcare system factors have contributed to the resulting epidemic of prescription opioid abuse. As the scope of this epidemic became evident, efforts to make abuse-deterrent formulations (ADFs) began, and many ADFs are under development. In January 2013, the US Food and Drug Administration (FDA) issued a Draft Guidance outlining the categories of studies needed for evaluating the abuse-deterrent properties of ADF opioids (e.g., pre-market in vitro, pharmacokinetic and abuse potential studies, and post-marketing studies) and the four potential label claims that might be made about the products. Studies to be conducted are those required for approval, those that might be included as data in the label (implicit claims), and those that would be required to merit a specific explicit claim—Tier 1, 2, 3, or 4. In the context of the Guidance, new ADFs need to consider the unique features of their technology, market size, comparator products, actual routes and methods of abuse, the targeted health consequences of abuse, pricing and reimbursement, the impact of other interventions to decrease abuse, and the challenges in doing post-market studies. ADFs will not stop prescription opioid drug abuse; however, easily tampered formulations should not contribute to the problem. All extended-release (ER) opioids and other abusable drugs should have abuse-deterrent properties. Immediate-release (IR) opioids should also be formulated with abuse-deterrent properties, because abuse of IR opioids is a more common and serious problem than that of ER opioids. Maximum dosage strengths of ER opioids should also be limited. Finally, the current situation, where non-abuse-deterrent ER opioids exist concurrently on the market is extremely problematic from a public health policy perspective.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Draft Guidance</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">OxyContin</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Prescription Drug Abuse</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Prescription Opioid Abuse</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Opana</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Shram, Megan J.</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Schoedel, Kerri A.</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">Pharmaceutical medicine</subfield><subfield code="d">Auckland : Wolters Kluwer Health Adis, 2008</subfield><subfield code="g">28(2014), 6 vom: 08. Okt., Seite 317-327</subfield><subfield code="w">(DE-627)56017375X</subfield><subfield code="w">(DE-600)2415180-4</subfield><subfield code="x">1179-1993</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:28</subfield><subfield code="g">year:2014</subfield><subfield code="g">number:6</subfield><subfield code="g">day:08</subfield><subfield code="g">month:10</subfield><subfield code="g">pages:317-327</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://dx.doi.org/10.1007/s40290-014-0067-1</subfield><subfield code="z">lizenzpflichtig</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_SPRINGER</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SSG-OLC-PHA</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_11</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_20</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_22</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_23</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_24</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_31</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_32</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_39</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_40</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_60</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_62</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_63</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_65</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_69</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_70</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_73</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_74</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_90</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_95</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_100</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_101</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_105</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_120</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_138</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_150</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_151</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_161</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_170</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_171</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_187</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_206</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_213</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_224</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_230</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_250</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_266</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_281</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_285</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_293</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_370</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_602</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_636</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_702</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2001</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2003</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2004</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2005</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2006</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2007</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2008</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2009</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2010</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2011</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2014</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2015</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2020</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2021</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2025</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2026</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2027</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2031</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2034</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2037</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2038</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2039</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2044</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2048</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2049</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2050</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2055</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2057</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2059</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2061</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2064</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2065</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2068</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2088</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2093</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2106</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2107</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2108</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2111</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2112</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2113</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2118</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2129</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2143</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2144</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2147</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2148</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2152</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2153</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2188</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2190</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2232</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2336</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2446</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2470</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2507</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2522</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2548</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4035</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4037</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4046</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4112</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4125</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4242</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4246</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4249</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4251</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4305</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4306</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4307</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4313</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4322</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4323</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4324</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4325</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4326</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4333</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4334</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4335</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4336</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4338</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4393</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4700</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">28</subfield><subfield code="j">2014</subfield><subfield code="e">6</subfield><subfield code="b">08</subfield><subfield code="c">10</subfield><subfield code="h">317-327</subfield></datafield></record></collection>
|
| score |
7.4008656 |