Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India
Abstract This article describes regulatory approaches for approval of “generic” orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device si...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Lee, Sau L. [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2015 |
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| Schlagwörter: |
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| Anmerkung: |
© American Association of Pharmaceutical Scientists 2015 |
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| Übergeordnetes Werk: |
Enthalten in: AAPS PharmSci - Arlington, Va. : Soc., 1999, 17(2015), 5 vom: 23. Mai, Seite 1285-1304 |
|---|---|
| Übergeordnetes Werk: |
volume:17 ; year:2015 ; number:5 ; day:23 ; month:05 ; pages:1285-1304 |
| Links: |
|---|
| DOI / URN: |
10.1208/s12248-015-9787-8 |
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SPR024737542 |
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| 520 | |a Abstract This article describes regulatory approaches for approval of “generic” orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the “original” product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as “generic” and “reference” drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches. | ||
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10.1208/s12248-015-9787-8 doi (DE-627)SPR024737542 (SPR)s12248-015-9787-8-e DE-627 ger DE-627 rakwb eng Lee, Sau L. verfasserin aut Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © American Association of Pharmaceutical Scientists 2015 Abstract This article describes regulatory approaches for approval of “generic” orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the “original” product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as “generic” and “reference” drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches. bioequivalence (dpeaa)DE-He213 emerging markets (dpeaa)DE-He213 generics (dpeaa)DE-He213 pMDIs and DPIs (dpeaa)DE-He213 regulatory requirements (dpeaa)DE-He213 Saluja, Bhawana aut García-Arieta, Alfredo aut Santos, Gustavo Mendes Lima aut Li, Ying aut Lu, Sarah aut Hou, Shuguang aut Rebello, Juliet aut Vaidya, Abhijit aut Gogtay, Jaideep aut Purandare, Shrinivas aut Lyapustina, Svetlana aut Enthalten in AAPS PharmSci Arlington, Va. : Soc., 1999 17(2015), 5 vom: 23. Mai, Seite 1285-1304 (DE-627)328321060 (DE-600)2045715-7 1522-1059 nnns volume:17 year:2015 number:5 day:23 month:05 pages:1285-1304 https://dx.doi.org/10.1208/s12248-015-9787-8 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 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_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 AR 17 2015 5 23 05 1285-1304 |
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10.1208/s12248-015-9787-8 doi (DE-627)SPR024737542 (SPR)s12248-015-9787-8-e DE-627 ger DE-627 rakwb eng Lee, Sau L. verfasserin aut Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © American Association of Pharmaceutical Scientists 2015 Abstract This article describes regulatory approaches for approval of “generic” orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the “original” product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as “generic” and “reference” drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches. bioequivalence (dpeaa)DE-He213 emerging markets (dpeaa)DE-He213 generics (dpeaa)DE-He213 pMDIs and DPIs (dpeaa)DE-He213 regulatory requirements (dpeaa)DE-He213 Saluja, Bhawana aut García-Arieta, Alfredo aut Santos, Gustavo Mendes Lima aut Li, Ying aut Lu, Sarah aut Hou, Shuguang aut Rebello, Juliet aut Vaidya, Abhijit aut Gogtay, Jaideep aut Purandare, Shrinivas aut Lyapustina, Svetlana aut Enthalten in AAPS PharmSci Arlington, Va. : Soc., 1999 17(2015), 5 vom: 23. Mai, Seite 1285-1304 (DE-627)328321060 (DE-600)2045715-7 1522-1059 nnns volume:17 year:2015 number:5 day:23 month:05 pages:1285-1304 https://dx.doi.org/10.1208/s12248-015-9787-8 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 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_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 AR 17 2015 5 23 05 1285-1304 |
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10.1208/s12248-015-9787-8 doi (DE-627)SPR024737542 (SPR)s12248-015-9787-8-e DE-627 ger DE-627 rakwb eng Lee, Sau L. verfasserin aut Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © American Association of Pharmaceutical Scientists 2015 Abstract This article describes regulatory approaches for approval of “generic” orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the “original” product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as “generic” and “reference” drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches. bioequivalence (dpeaa)DE-He213 emerging markets (dpeaa)DE-He213 generics (dpeaa)DE-He213 pMDIs and DPIs (dpeaa)DE-He213 regulatory requirements (dpeaa)DE-He213 Saluja, Bhawana aut García-Arieta, Alfredo aut Santos, Gustavo Mendes Lima aut Li, Ying aut Lu, Sarah aut Hou, Shuguang aut Rebello, Juliet aut Vaidya, Abhijit aut Gogtay, Jaideep aut Purandare, Shrinivas aut Lyapustina, Svetlana aut Enthalten in AAPS PharmSci Arlington, Va. : Soc., 1999 17(2015), 5 vom: 23. Mai, Seite 1285-1304 (DE-627)328321060 (DE-600)2045715-7 1522-1059 nnns volume:17 year:2015 number:5 day:23 month:05 pages:1285-1304 https://dx.doi.org/10.1208/s12248-015-9787-8 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 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_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 AR 17 2015 5 23 05 1285-1304 |
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10.1208/s12248-015-9787-8 doi (DE-627)SPR024737542 (SPR)s12248-015-9787-8-e DE-627 ger DE-627 rakwb eng Lee, Sau L. verfasserin aut Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © American Association of Pharmaceutical Scientists 2015 Abstract This article describes regulatory approaches for approval of “generic” orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the “original” product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as “generic” and “reference” drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches. bioequivalence (dpeaa)DE-He213 emerging markets (dpeaa)DE-He213 generics (dpeaa)DE-He213 pMDIs and DPIs (dpeaa)DE-He213 regulatory requirements (dpeaa)DE-He213 Saluja, Bhawana aut García-Arieta, Alfredo aut Santos, Gustavo Mendes Lima aut Li, Ying aut Lu, Sarah aut Hou, Shuguang aut Rebello, Juliet aut Vaidya, Abhijit aut Gogtay, Jaideep aut Purandare, Shrinivas aut Lyapustina, Svetlana aut Enthalten in AAPS PharmSci Arlington, Va. : Soc., 1999 17(2015), 5 vom: 23. Mai, Seite 1285-1304 (DE-627)328321060 (DE-600)2045715-7 1522-1059 nnns volume:17 year:2015 number:5 day:23 month:05 pages:1285-1304 https://dx.doi.org/10.1208/s12248-015-9787-8 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 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_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 AR 17 2015 5 23 05 1285-1304 |
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10.1208/s12248-015-9787-8 doi (DE-627)SPR024737542 (SPR)s12248-015-9787-8-e DE-627 ger DE-627 rakwb eng Lee, Sau L. verfasserin aut Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © American Association of Pharmaceutical Scientists 2015 Abstract This article describes regulatory approaches for approval of “generic” orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the “original” product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as “generic” and “reference” drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches. bioequivalence (dpeaa)DE-He213 emerging markets (dpeaa)DE-He213 generics (dpeaa)DE-He213 pMDIs and DPIs (dpeaa)DE-He213 regulatory requirements (dpeaa)DE-He213 Saluja, Bhawana aut García-Arieta, Alfredo aut Santos, Gustavo Mendes Lima aut Li, Ying aut Lu, Sarah aut Hou, Shuguang aut Rebello, Juliet aut Vaidya, Abhijit aut Gogtay, Jaideep aut Purandare, Shrinivas aut Lyapustina, Svetlana aut Enthalten in AAPS PharmSci Arlington, Va. : Soc., 1999 17(2015), 5 vom: 23. Mai, Seite 1285-1304 (DE-627)328321060 (DE-600)2045715-7 1522-1059 nnns volume:17 year:2015 number:5 day:23 month:05 pages:1285-1304 https://dx.doi.org/10.1208/s12248-015-9787-8 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 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_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 AR 17 2015 5 23 05 1285-1304 |
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Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India |
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Abstract This article describes regulatory approaches for approval of “generic” orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the “original” product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as “generic” and “reference” drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches. © American Association of Pharmaceutical Scientists 2015 |
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Abstract This article describes regulatory approaches for approval of “generic” orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the “original” product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as “generic” and “reference” drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches. © American Association of Pharmaceutical Scientists 2015 |
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Abstract This article describes regulatory approaches for approval of “generic” orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the “original” product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as “generic” and “reference” drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches. © American Association of Pharmaceutical Scientists 2015 |
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This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as “generic” and “reference” drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. 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