title: Clinical safety and pharmacology trial.
abstract: Guidelines for establishing clinical safety of microbicides in early clinical studies have evolved significantly since the first trials. In addition, because of the difficulty of establishing efficacy of a microbicide prior to Phase III testing, there has been an increasing emphasis on establishing pharmacokinetic (PK)/pharmacodynamic (PD) relationships using genital samples collected in vivo in Phase I studies. A healthy pipeline is critical to success; however, it is unlikely that the majority of microbicide candidates will progress to clinical testing. Those that do enter clinical testing may have different mechanisms of action than early candidates. Given this, drug-specific modifications for early clinical assessment will need to be considered. These emerging issues associated with early clinical trials of microbicides will be reviewed, along with recommendations for future clinical safety and PK/PD evaluation.
authors.affiliation: CONRAD, 1911 North Fort Myer Drive, Suite 900, Arlington, VA, 22209, USA, cmauck@conrad.org.
authors.forename: Christine
authors.initials: C
authors.lastname: Mauck
authors.forename: Andrea
authors.initials: A
authors.lastname: Thurman
authors.forename: Jill
authors.initials: J
authors.lastname: Schwartz
mesh_terms: D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000493:pharmacokinetics*; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical / Q000295:instrumentation / Q000379:methods; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D007109:Immunity / Q000187:drug effects
chemical_list: D019380:Anti-HIV Agents