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Clinical Pharmacology Aspects of Sex‐Related Drug Products
Author(s) -
Tran D C,
Apparaju S,
Yu C,
Lee L,
Kim H,
Kim MJ
Publication year - 2011
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.2010.270
Subject(s) - clinical pharmacology , pharmacology , drug , pharmacogenomics , medicine , drug development , pharmacokinetics , food and drug administration
Clinical pharmacology plays an important role in drug development, including evaluation of a drug's pharmacokinetics (PK), interaction potential, exposure–response relationship, and pharmacogenomics ( Table 1 ). Reviewers in the Office of Clinical Pharmacology at the US Food and Drug Administration (FDA) consider these issues to facilitate drug development and to ensure that drug products are safe and effective. This article highlights some of the important clinical pharmacology topics in the development of sex‐related drug products. Clinical Pharmacology & Therapeutics (2011) 89 1, 26–28. doi: 10.1038/clpt.2010.270