Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2011 Jan;89(1):26-8. doi: 10.1038/clpt.2010.270.
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.
临床药理学在药物开发中起着重要作用，包括评估药物的药代动力学（PK）、相互作用潜力、暴露-反应关系和药物基因组学（表 1）。美国食品和药物管理局（FDA）临床药理学办公室的审查员考虑这些问题以促进药物开发并确保药物产品的安全性和有效性。本文重点介绍了性相关药物产品开发中一些重要的临床药理学主题。
