Shiew-Mei Huang, John M Strong, Lei Zhang, Kellie S Reynolds, Srikanth Nallani, Robert Temple, Sophia Abraham, Sayed Al Habet, Raman K Baweja, Gilbert J Burckart, Sang Chung, Philip Colangelo, David Frucht, Martin D Green, Paul Hepp, Elena Karnaukhova, Hon-Sum Ko, Jang-Ik Lee, Patrick J Marroum, Janet M Norden, Wei Qiu, Atiqur Rahman, Solomon Sobel, Toni Stifano, Kenneth Thummel, Xiao-Xiong Wei, Sally Yasuda, Jenny H Zheng, Hong Zhao, Lawrence J Lesko
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...
June 2008: Journal of Clinical Pharmacology