title: Clinical pharmacology aspects of sex-related drug products.
abstract: 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.
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: D C
authors.initials: DC
authors.lastname: Tran
authors.forename: S
authors.initials: S
authors.lastname: Apparaju
authors.forename: C
authors.initials: C
authors.lastname: Yu
authors.forename: L
authors.initials: L
authors.lastname: Lee
authors.forename: H
authors.initials: H
authors.lastname: Kim
authors.forename: M-J
authors.initials: MJ
authors.lastname: Kim
mesh_terms: D017277:Drug Approval; D004348:Drug Labeling / Q000639:trends; D015507:Drugs, Investigational / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008297:Male; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational