title: Therapeutic protein-drug interactions and implications for drug development.
abstract: Many intrinsic and extrinsic factors can affect an individual patient's drug exposure and response. The US Food and Drug Administration (FDA) has published a number of guidances that recommend how and when to evaluate these factors during drug development. The most recent FDA draft guidance on drug interactions provides advice for in vitro and in vivo drug interaction studies, including suggestions for study design, dosing strategies and analysis, and interpretation of data for medical product labels. The draft guidance updated the FDA's recommendations on the evaluation of important cytochrome P450 (CYP) enzyme- and transporter-based drug interactions during drug development.
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. shiewmei.huang@fda.hhs.gov
authors.forename: S-M
authors.initials: SM
authors.lastname: Huang
authors.forename: H
authors.initials: H
authors.lastname: Zhao
authors.forename: J-I
authors.initials: JI
authors.lastname: Lee
authors.forename: K
authors.initials: K
authors.lastname: Reynolds
authors.forename: L
authors.initials: L
authors.lastname: Zhang
authors.forename: R
authors.initials: R
authors.lastname: Temple
authors.forename: L J
authors.initials: LJ
authors.lastname: Lesko
mesh_terms: D000818:Animals; D001692:Biological Transport / Q000187:drug effects; D002986:Clinical Trials as Topic / Q000379:methods*; D003577:Cytochrome P-450 Enzyme System / Q000187:drug effects / Q000378:metabolism; D015195:Drug Design; D004347:Drug Interactions; D004348:Drug Labeling; D017408:Guidelines as Topic; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D003577:Cytochrome P-450 Enzyme System