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New Era in Drug Interaction Evaluation: US Food and Drug Administration Update on CYP Enzymes, Transporters, and the Guidance Process.

Authors :
Shiew-Mei Huang
Strong, John M.
Lei Zhang
Reynolds, Kellie S.
Nallani, Srikanth
Temple, Robert
Abraham, Ophia
Habet, Sayed Al
Baweja, Raman K.
Burckart, Gilbert J.
Sang Chung
Colangelo, Philip
Frucht, David
Green, Martin D.
Hepp, Paul
Karnaukhova, Elena
Hon-Sum Ko
Jan G-Ik Lee
Marroum, Patrick J.
Norden, Janet M.
Source :
Journal of Clinical Pharmacology; Jun2008, Vol. 48 Issue 6, p662-670, 9p, 1 Chart
Publication Year :
2008

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 under- standing of drug interactions (http://www.fda.gov/cder/drug/druglnteractions/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. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
00912700
Volume :
48
Issue :
6
Database :
Complementary Index
Journal :
Journal of Clinical Pharmacology
Publication Type :
Academic Journal
Accession number :
34182165
Full Text :
https://doi.org/10.1177/0091270007312153