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Current Opinion in HIV & AIDS:
doi: 10.1097/COH.0b013e32830891e2
Microbicides: Edited by John Kaldor and Melissa Robbiani

Microbicide product development

Maguire, Robin

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Abstract

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.

© 2008 Lippincott Williams & Wilkins, Inc.

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