Applied Pharmacokinetics in Drug Development
Abstract The process of discovering, developing, and marketing new drugs has changed considerably in the last decade; however, the cost associated with this process remains staggeringly high. Although there are many reasons for this high cost, one reason appears to be the continuing high attrition r...
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Gespeichert in:
| Autor*in: |
Caldwell, Gary W. [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2003 |
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| Schlagwörter: |
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| Anmerkung: |
© Adis Data Information BV 2003 |
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| Übergeordnetes Werk: |
Enthalten in: Pharmaceutical Development and Regulation - Springer International Publishing, 2003, 1(2003), 2 vom: Juni, Seite 117-132 |
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| Übergeordnetes Werk: |
volume:1 ; year:2003 ; number:2 ; month:06 ; pages:117-132 |
| Links: |
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| DOI / URN: |
10.1007/BF03257371 |
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| 520 | |a Abstract The process of discovering, developing, and marketing new drugs has changed considerably in the last decade; however, the cost associated with this process remains staggeringly high. Although there are many reasons for this high cost, one reason appears to be the continuing high attrition rates of drugs during costly early- and late-stage human clinical trials. To address this problem, drug discovery organizations are striving to rapidly identify high-potential drug candidates and eliminate as early as possible those with inferior potency, poor pharmacokinetic properties, and toxicity problems, so that these deficient drug candidates do not incur the high costs of clinical trials. During the last 5 years, a decision-making go/no-go strategy has been introduced into the drug discovery process, using pharmacokinetic principles to minimize the risks and maximize the benefits of selecting superior drug candidates. Pharmacological deficiencies are related in part to pharmacokinetic properties. To understand this process, a brief review of pharmacokinetic properties including oral bioavailability, half-life, absorption, clearance, and volume of distribution is presented. We examine in vitro — in vivo (human) and/or in vivo (animals) — in vivo (human) correlations for several of these pharmacokinetic properties, followed by a discussion of how this preclinical information is collected and used in drug discovery at the various stages to select drug candidates. Finally, we summarize how these methods are used to make go/no-go decisions in each step of the drug discovery process. | ||
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| 700 | 1 | |a Leo, Gregory |4 aut | |
| 700 | 1 | |a Ritchie, David M. |4 aut | |
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10.1007/BF03257371 doi (DE-627)SPR03647925X (SPR)BF03257371-e DE-627 ger DE-627 rakwb eng Caldwell, Gary W. verfasserin aut Applied Pharmacokinetics in Drug Development 2003 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Adis Data Information BV 2003 Abstract The process of discovering, developing, and marketing new drugs has changed considerably in the last decade; however, the cost associated with this process remains staggeringly high. Although there are many reasons for this high cost, one reason appears to be the continuing high attrition rates of drugs during costly early- and late-stage human clinical trials. To address this problem, drug discovery organizations are striving to rapidly identify high-potential drug candidates and eliminate as early as possible those with inferior potency, poor pharmacokinetic properties, and toxicity problems, so that these deficient drug candidates do not incur the high costs of clinical trials. During the last 5 years, a decision-making go/no-go strategy has been introduced into the drug discovery process, using pharmacokinetic principles to minimize the risks and maximize the benefits of selecting superior drug candidates. Pharmacological deficiencies are related in part to pharmacokinetic properties. To understand this process, a brief review of pharmacokinetic properties including oral bioavailability, half-life, absorption, clearance, and volume of distribution is presented. We examine in vitro — in vivo (human) and/or in vivo (animals) — in vivo (human) correlations for several of these pharmacokinetic properties, followed by a discussion of how this preclinical information is collected and used in drug discovery at the various stages to select drug candidates. Finally, we summarize how these methods are used to make go/no-go decisions in each step of the drug discovery process. Drug Discovery (dpeaa)DE-He213 Oral Bioavailability (dpeaa)DE-He213 Drug Candidate (dpeaa)DE-He213 Drug Discovery Process (dpeaa)DE-He213 Drug Lead (dpeaa)DE-He213 Yan, Zhengyin aut Masucci, John A. aut Hageman, William aut Leo, Gregory aut Ritchie, David M. aut Enthalten in Pharmaceutical Development and Regulation Springer International Publishing, 2003 1(2003), 2 vom: Juni, Seite 117-132 (DE-627)SPR036479128 nnns volume:1 year:2003 number:2 month:06 pages:117-132 https://dx.doi.org/10.1007/BF03257371 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA AR 1 2003 2 06 117-132 |
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10.1007/BF03257371 doi (DE-627)SPR03647925X (SPR)BF03257371-e DE-627 ger DE-627 rakwb eng Caldwell, Gary W. verfasserin aut Applied Pharmacokinetics in Drug Development 2003 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Adis Data Information BV 2003 Abstract The process of discovering, developing, and marketing new drugs has changed considerably in the last decade; however, the cost associated with this process remains staggeringly high. Although there are many reasons for this high cost, one reason appears to be the continuing high attrition rates of drugs during costly early- and late-stage human clinical trials. To address this problem, drug discovery organizations are striving to rapidly identify high-potential drug candidates and eliminate as early as possible those with inferior potency, poor pharmacokinetic properties, and toxicity problems, so that these deficient drug candidates do not incur the high costs of clinical trials. During the last 5 years, a decision-making go/no-go strategy has been introduced into the drug discovery process, using pharmacokinetic principles to minimize the risks and maximize the benefits of selecting superior drug candidates. Pharmacological deficiencies are related in part to pharmacokinetic properties. To understand this process, a brief review of pharmacokinetic properties including oral bioavailability, half-life, absorption, clearance, and volume of distribution is presented. We examine in vitro — in vivo (human) and/or in vivo (animals) — in vivo (human) correlations for several of these pharmacokinetic properties, followed by a discussion of how this preclinical information is collected and used in drug discovery at the various stages to select drug candidates. Finally, we summarize how these methods are used to make go/no-go decisions in each step of the drug discovery process. Drug Discovery (dpeaa)DE-He213 Oral Bioavailability (dpeaa)DE-He213 Drug Candidate (dpeaa)DE-He213 Drug Discovery Process (dpeaa)DE-He213 Drug Lead (dpeaa)DE-He213 Yan, Zhengyin aut Masucci, John A. aut Hageman, William aut Leo, Gregory aut Ritchie, David M. aut Enthalten in Pharmaceutical Development and Regulation Springer International Publishing, 2003 1(2003), 2 vom: Juni, Seite 117-132 (DE-627)SPR036479128 nnns volume:1 year:2003 number:2 month:06 pages:117-132 https://dx.doi.org/10.1007/BF03257371 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA AR 1 2003 2 06 117-132 |
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10.1007/BF03257371 doi (DE-627)SPR03647925X (SPR)BF03257371-e DE-627 ger DE-627 rakwb eng Caldwell, Gary W. verfasserin aut Applied Pharmacokinetics in Drug Development 2003 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Adis Data Information BV 2003 Abstract The process of discovering, developing, and marketing new drugs has changed considerably in the last decade; however, the cost associated with this process remains staggeringly high. Although there are many reasons for this high cost, one reason appears to be the continuing high attrition rates of drugs during costly early- and late-stage human clinical trials. To address this problem, drug discovery organizations are striving to rapidly identify high-potential drug candidates and eliminate as early as possible those with inferior potency, poor pharmacokinetic properties, and toxicity problems, so that these deficient drug candidates do not incur the high costs of clinical trials. During the last 5 years, a decision-making go/no-go strategy has been introduced into the drug discovery process, using pharmacokinetic principles to minimize the risks and maximize the benefits of selecting superior drug candidates. Pharmacological deficiencies are related in part to pharmacokinetic properties. To understand this process, a brief review of pharmacokinetic properties including oral bioavailability, half-life, absorption, clearance, and volume of distribution is presented. We examine in vitro — in vivo (human) and/or in vivo (animals) — in vivo (human) correlations for several of these pharmacokinetic properties, followed by a discussion of how this preclinical information is collected and used in drug discovery at the various stages to select drug candidates. Finally, we summarize how these methods are used to make go/no-go decisions in each step of the drug discovery process. Drug Discovery (dpeaa)DE-He213 Oral Bioavailability (dpeaa)DE-He213 Drug Candidate (dpeaa)DE-He213 Drug Discovery Process (dpeaa)DE-He213 Drug Lead (dpeaa)DE-He213 Yan, Zhengyin aut Masucci, John A. aut Hageman, William aut Leo, Gregory aut Ritchie, David M. aut Enthalten in Pharmaceutical Development and Regulation Springer International Publishing, 2003 1(2003), 2 vom: Juni, Seite 117-132 (DE-627)SPR036479128 nnns volume:1 year:2003 number:2 month:06 pages:117-132 https://dx.doi.org/10.1007/BF03257371 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA AR 1 2003 2 06 117-132 |
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Abstract The process of discovering, developing, and marketing new drugs has changed considerably in the last decade; however, the cost associated with this process remains staggeringly high. Although there are many reasons for this high cost, one reason appears to be the continuing high attrition rates of drugs during costly early- and late-stage human clinical trials. To address this problem, drug discovery organizations are striving to rapidly identify high-potential drug candidates and eliminate as early as possible those with inferior potency, poor pharmacokinetic properties, and toxicity problems, so that these deficient drug candidates do not incur the high costs of clinical trials. During the last 5 years, a decision-making go/no-go strategy has been introduced into the drug discovery process, using pharmacokinetic principles to minimize the risks and maximize the benefits of selecting superior drug candidates. Pharmacological deficiencies are related in part to pharmacokinetic properties. To understand this process, a brief review of pharmacokinetic properties including oral bioavailability, half-life, absorption, clearance, and volume of distribution is presented. We examine in vitro — in vivo (human) and/or in vivo (animals) — in vivo (human) correlations for several of these pharmacokinetic properties, followed by a discussion of how this preclinical information is collected and used in drug discovery at the various stages to select drug candidates. Finally, we summarize how these methods are used to make go/no-go decisions in each step of the drug discovery process. © Adis Data Information BV 2003 |
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Abstract The process of discovering, developing, and marketing new drugs has changed considerably in the last decade; however, the cost associated with this process remains staggeringly high. Although there are many reasons for this high cost, one reason appears to be the continuing high attrition rates of drugs during costly early- and late-stage human clinical trials. To address this problem, drug discovery organizations are striving to rapidly identify high-potential drug candidates and eliminate as early as possible those with inferior potency, poor pharmacokinetic properties, and toxicity problems, so that these deficient drug candidates do not incur the high costs of clinical trials. During the last 5 years, a decision-making go/no-go strategy has been introduced into the drug discovery process, using pharmacokinetic principles to minimize the risks and maximize the benefits of selecting superior drug candidates. Pharmacological deficiencies are related in part to pharmacokinetic properties. To understand this process, a brief review of pharmacokinetic properties including oral bioavailability, half-life, absorption, clearance, and volume of distribution is presented. We examine in vitro — in vivo (human) and/or in vivo (animals) — in vivo (human) correlations for several of these pharmacokinetic properties, followed by a discussion of how this preclinical information is collected and used in drug discovery at the various stages to select drug candidates. Finally, we summarize how these methods are used to make go/no-go decisions in each step of the drug discovery process. © Adis Data Information BV 2003 |
| abstract_unstemmed |
Abstract The process of discovering, developing, and marketing new drugs has changed considerably in the last decade; however, the cost associated with this process remains staggeringly high. Although there are many reasons for this high cost, one reason appears to be the continuing high attrition rates of drugs during costly early- and late-stage human clinical trials. To address this problem, drug discovery organizations are striving to rapidly identify high-potential drug candidates and eliminate as early as possible those with inferior potency, poor pharmacokinetic properties, and toxicity problems, so that these deficient drug candidates do not incur the high costs of clinical trials. During the last 5 years, a decision-making go/no-go strategy has been introduced into the drug discovery process, using pharmacokinetic principles to minimize the risks and maximize the benefits of selecting superior drug candidates. Pharmacological deficiencies are related in part to pharmacokinetic properties. To understand this process, a brief review of pharmacokinetic properties including oral bioavailability, half-life, absorption, clearance, and volume of distribution is presented. We examine in vitro — in vivo (human) and/or in vivo (animals) — in vivo (human) correlations for several of these pharmacokinetic properties, followed by a discussion of how this preclinical information is collected and used in drug discovery at the various stages to select drug candidates. Finally, we summarize how these methods are used to make go/no-go decisions in each step of the drug discovery process. © Adis Data Information BV 2003 |
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Applied Pharmacokinetics in Drug Development |
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Yan, Zhengyin Masucci, John A. Hageman, William Leo, Gregory Ritchie, David M. |
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