Microbicide product development.
OBJECTIVE
The purpose of this overview is to summarize the essential parameters needed to establish a sound microbicide development strategy.


RESULTS
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.


CONCLUSIONS
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.
Population Council, New York, New York 10065, USA. rmaguire@popcouncil.org
Robin
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Maguire