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

Author:

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

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

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3. Evaluation of Drugs in Women: Regulatory Perspective

4. US Food and Drug Administration Center for Drug Evaluation and Research http:www.fda.govcderarchivesdefault.htm 2007

5. US Food and Drug Administration Guidance for Industry: Drug Metabolism/Drug Interactions in the Drug Development Process: Studies in vitro 1997 http:www.fda.govCderguidanceclin3.pdf http:www.fda.govcderdrugdrugInteractionsdefault.htm

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