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Microbicide product development

Maguire, Robin

Current Opinion in HIV and AIDS: September 2008 - Volume 3 - Issue 5 - p 554–557
doi: 10.1097/COH.0b013e32830891e2
Microbicides: Edited by John Kaldor and Melissa Robbiani

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.

Population Council, New York, New York, USA

Correspondence to Robin Maguire, Population Council, 1230 York Avenue, New York, NY, 10065, USA Tel: +1 212 327 8729; fax: +1 212 327 7981; e-mail: rmaguire@popcouncil.org

© 2008 Lippincott Williams & Wilkins, Inc.