Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review
| Autor: | T. C. Wu, Nam Atiqur Rahman, S. S. Brar, Lei Zhang, Lawrence J. Lesko, Rajnikanth Madabushi, Qi Liu, P. Song, Y. J. Moon, Brian Booth, Joseph A. Grillo, Huang Sm, E Gil Berglund, Kellie S. Reynolds, Ping Zhao, Julie Bullock |
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| Rok vydání: | 2010 |
| Předmět: |
Drug
Physiologically based pharmacokinetic modelling Physiology media_common.quotation_subject Pharmacology Models Biological law.invention Modeling and simulation Pharmacokinetics law Medicine Humans Pharmacology (medical) Computer Simulation Investigational New Drug Application Drug Approval media_common Clinical pharmacology Management science business.industry United States Food and Drug Administration Clinical study design United States Drug development Drug and Narcotic Control business |
| Zdroj: | Clinical pharmacology and therapeutics. 89(2) |
| ISSN: | 1532-6535 |
| Popis: | Physiologically based pharmacokinetic (PBPK) modeling and simulation is a tool that can help predict the pharmacokinetics of drugs in humans and evaluate the effects of intrinsic (e.g., organ dysfunction, age, genetics) and extrinsic (e.g., drug-drug interactions) factors, alone or in combinations, on drug exposure. The use of this tool is increasing at all stages of the drug development process. This report reviews recent instances of the use of PBPK in decision-making during regulatory review. The examples are based on Center for Drug Evaluation and Research reviews of several submissions for investigational new drugs (INDs) and new drug applications (NDAs) received between July 2008 and June 2010. The use of PBPK modeling and simulation facilitated the following types of decisions: the need to conduct specific clinical pharmacology studies, specific study designs, and appropriate labeling language. The report also discusses the challenges encountered when PBPK modeling and simulation were used in these cases and recommends approaches to facilitating full utilization of this tool. |
| Databáze: | OpenAIRE |
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