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Therapeutic Protein–Drug Interactions and Implications for Drug Development
Author(s) -
Huang SM,
Zhao H,
Lee JI,
Reynolds K,
Zhang L,
Temple R,
Lesko L J
Publication year - 2010
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2009.308
Subject(s) - drug , drug development , pharmacology , food and drug administration , dosing , medicine , drug interaction , approved drug
Many intrinsic and extrinsic factors can affect an individual patient's drug exposure and response. 1 The US Food and Drug Administration (FDA) has published a number of guidances that recommend how and when to evaluate these factors during drug development. 2 The most recent FDA draft guidance on drug interactions 3 provides advice for in vitro and in vivo drug interaction studies, including suggestions for study design, dosing strategies and analysis, and interpretation of data for medical product labels. The draft guidance 3 updated the FDA's recommendations on the evaluation of important cytochrome P450 (CYP) enzyme‐ and transporter‐based drug interactions during drug development. Clinical Pharmacology & Therapeutics (2010) 87 4, 497–503. doi: 10.1038/clpt.2009.308