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DRUG INTERACTIONS/REVIEW

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

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

From the Office of Clinical Pharmacology (Dr Huang, Dr Zhang, Dr Reynolds, Dr Nallani, Dr Abraham, Dr Al Habet, Dr Baweja, Dr Chung, Dr Colangelo, Dr Hepp, Dr Lee, Dr Marroum, Dr Qiu, Dr Rahman, Dr Wei, Dr Yasuda, Dr Zheng, Dr Zhao, Dr Lesko), Office of Pharmaceutical Science (Dr Strong, Dr Frucht), and Office of Medical Policy (Dr Temple, Dr Norden), Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland; Office of Blood Research and Review (Dr Ko, Dr Karnaukhova) and Office of Vaccine Research and Review (Dr Green), Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, Maryland; Department of Pharmacy, University of Southern California (Dr Burckart), Los Angeles, California; and Department of Pharmaceutics, University of Washington (Dr Thummel), Seattle, Washington.

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.

Key Words: Drug interactions • transporter proteins • P-glycoprotein • cytochrome P450 enzymes • inhibition • induction • pharmacogenetics

Address for reprints: Shiew-Mei Huang, PhD, FCP, Office of Clinical Pharmacology, CDER, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993.






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