title: PBPK as a tool in regulatory review.
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences-OTS, Center for Drug Evaluation and Research-CDER, Food and Drug Administration-FDA, Silver Spring, MD, USA. ShiewMei.Huang@fda.hhs.gov
authors.forename: Shiew-Mei
authors.initials: SM
authors.lastname: Huang
mesh_terms: D000818:Animals; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D008954:Models, Biological; D004364:Pharmaceutical Preparations / Q000378:metabolism; D010599:Pharmacokinetics; D010829:Physiological Phenomena / Q000502:physiology
chemical_list: D004364:Pharmaceutical Preparations