Microbicide product development.

Purpose Of Review: The purpose of this overview is to summarize the essential parameters needed to establish a sound microbicide development strategy.

Recent Findings: In recent years more comprehensive regulatory guidelines that are applicable to microbicides have been developed. Additionally, the US Food and Drug Administration have begun providing specific guidance for microbicide development.

Summary: Microbicide product development has been aided in recent years by new regulatory guidance that helps to establish a stepwise development strategy. Developing comprehensive profiles for three key criteria - quality, safety and efficacy - are essential for preparation of an investigational new drug application that will allow proceeding into clinical development to establish microbicide proof-of-concept.