title: Impact of physiologically based pharmacokinetic models on regulatory reviews and product labels: Frequent utilization in the field of oncology.
abstract: Physiologically based pharmacokinetic (PBPK) modeling can be used to predict drug pharmacokinetics in virtual populations using models that integrate understanding of physiological systems. PBPK models have been widely utilized for predicting pharmacokinetics in clinically untested scenarios during drug applications and regulatory reviews in recent years. Here, we provide a comprehensive review of the application of PBPK in new drug application (NDA) review documents from the US Food and Drug Administration (FDA) in the past 4 years.
authors.affiliation: Department of Clinical Pharmacology, Genentech Research and Early Development, South San Francisco, California, USA.
authors.forename: K
authors.initials: K
authors.lastname: Yoshida
authors.affiliation: Department of Clinical Pharmacology, Genentech Research and Early Development, South San Francisco, California, USA.
authors.forename: N
authors.initials: N
authors.lastname: Budha
authors.affiliation: Department of Clinical Pharmacology, Genentech Research and Early Development, South San Francisco, California, USA.
authors.forename: J Y
authors.initials: JY
authors.lastname: Jin
mesh_terms: D000970:Antineoplastic Agents / Q000493:pharmacokinetics*; D017277:Drug Approval; D004347:Drug Interactions; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D008495:Medical Oncology / Q000592:standards*; D008954:Models, Biological; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000970:Antineoplastic Agents