title: New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process.
abstract: Predicting clinically significant drug interactions during drug development is a challenge for the pharmaceutical industry and regulatory agencies. Since the publication of the US Food and Drug Administration's (FDA's) first in vitro and in vivo drug interaction guidance documents in 1997 and 1999, researchers and clinicians have gained a better understanding of drug interactions. This knowledge has enabled the FDA and the industry to progress and begin to overcome these challenges. The FDA has continued its efforts to evaluate methodologies to study drug interactions and communicate recommendations regarding the conduct of drug interaction studies, particularly for CYP-based and transporter-based drug interactions, to the pharmaceutical industry. A drug interaction Web site was established to document the FDA's current understanding of drug interactions (http://www.fda.gov/cder/drug/drugInteractions/default.htm). This report provides an overview of the evolution of the drug interaction guidances, includes a synopsis of the steps taken by the FDA to revise the original drug interaction guidance documents, and summarizes and highlights updated sections in the current guidance document, Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling.
authors: Office of Clinical Pharmacology, CDER, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors: Shiew-Mei
authors: SM
authors: Huang
authors: John M
authors: JM
authors: Strong
authors: Lei
authors: L
authors: Zhang
authors: Kellie S
authors: KS
authors: Reynolds
authors: Srikanth
authors: S
authors: Nallani
authors: Robert
authors: R
authors: Temple
authors: Sophia
authors: S
authors: Abraham
authors: Sayed Al
authors: SA
authors: Habet
authors: Raman K
authors: RK
authors: Baweja
authors: Gilbert J
authors: GJ
authors: Burckart
authors: Sang
authors: S
authors: Chung
authors: Philip
authors: P
authors: Colangelo
authors: David
authors: D
authors: Frucht
authors: Martin D
authors: MD
authors: Green
authors: Paul
authors: P
authors: Hepp
authors: Elena
authors: E
authors: Karnaukhova
authors: Hon-Sum
authors: HS
authors: Ko
authors: Jang-Ik
authors: JI
authors: Lee
authors: Patrick J
authors: PJ
authors: Marroum
authors: Janet M
authors: JM
authors: Norden
authors: Wei
authors: W
authors: Qiu
authors: Atiqur
authors: A
authors: Rahman
authors: Solomon
authors: S
authors: Sobel
authors: Toni
authors: T
authors: Stifano
authors: Kenneth
authors: K
authors: Thummel
authors: Xiao-Xiong
authors: XX
authors: Wei
authors: Sally
authors: S
authors: Yasuda
authors: Jenny H
authors: JH
authors: Zheng
authors: Hong
authors: H
authors: Zhao
authors: Lawrence J
authors: LJ
authors: Lesko
mesh_terms: D001692:Biological Transport / Q000187:drug effects; D003577:Cytochrome P-450 Enzyme System / Q000187:drug effects / Q000378:metabolism; D015195:Drug Design; D004347:Drug Interactions; D017408:Guidelines as Topic; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D003577:Cytochrome P-450 Enzyme System