Regulatory challenges in microbicide development.


This article describes some problems in the development of vaginal microbicides to prevent HIV infection. Large-scale clinical trials are needed; these are expensive and can last several years, during which many new HIV infections occur. Lack of well-definied criteria for licensure add to the problem. Developing countries with high HIV infection rates often have limited capacity for assessment of drugs; they often use approval in developed countries as a criterion for local approval, but different risk-benefit ratios in different countries mean that this is not always appropriate, and can make trials unnecessarily slow and expensive. Combinations of drugs require further trials. Measures taken to address the problem are described, and more are recommended.


Coplan, P.; Mitchnick, M.; Rosenberg, Z. PUBLIC HEALTH: Regulatory Challenges in Microbicide Development. Science (2004) 304 (5679) 1911-1912. [DOI: 10.1126/science.1100441]

Regulatory challenges in microbicide development.

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