论文信息 - Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory Questions

Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory Questions

Physiologically based pharmacokinetic (PBPK) models are increasingly used by drug developers to evaluate the effect of patient factors on drug exposure. Between June 2008 and December 2011, the Office of Clinical Pharmacology at the US Food and Drug Administration (FDA) received 25 submissions containing PBPK analyses. This report summarizes the essential content of a PBPK analysis needed in a regulatory submission for the purpose of addressing clinical pharmacology questions.

[1] Malcolm Rowland,et al. Physiologically-based pharmacokinetics in drug development and regulatory science. , 2011, Annual review of pharmacology and toxicology.

[2] S‐M Huang,et al. Is This the Drug or Dose for You?: Impact and Consideration of Ethnic Factors in Global Drug Development, Regulatory Review, and Clinical Practice , 2008, Clinical pharmacology and therapeutics.

[3] M Rowland,et al. The Role of Physiologically Based Pharmacokinetic Modeling in Regulatory Review , 2012, Clinical pharmacology and therapeutics.

[4] Amin Rostami-Hodjegan,et al. Simulation and prediction of in vivo drug metabolism in human populations from in vitro data , 2007, Nature Reviews Drug Discovery.

[5] L Zhang,et al. Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review , 2011, Clinical pharmacology and therapeutics.