Microbicide product development
Current Opinion in HIV and AIDS 3(5): 554-557
Publication date: 2008
Purpose of review
The purpose of this overview is to summarize the essential parameters needed to establish a sound microbicide development strategy.
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.
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.