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One of the most promising new approaches for the prevention of HIV transmission, particularly for developing countries, involves topical, self-administered products known as microbicides. The development of microbicides is a long and complicated process, and this volume provides an overview of all the critical areas, from the selection of appropriate candidate molecules and their formulation, preclinical and clinical testing for safety and efficacy, strategies for product registration and finally, issues associated with product launch, distribution and access. The book will prove valuable to both those working in the field and all others who are interested in learning more about this product class, which has the potential to significantly impact the future of this devastating epidemic.
List of contents
Candidate Microbicides and Their Mechanisms of Action.- Microbicide Dosage Forms.- Preclinical Safety Evaluation.- Clinical Safety and Pharmacology Trial.- Microbicides for Prevention of HIV Infection: Clinical Efficacy Trials.- Rectal Microbicide Development.- Developing Regulatory Strategy for Microbicides.- Preparing for Microbicide Introduction, Rollout and Sustained Access.
Summary
One of the most promising new approaches for the prevention of HIV transmission, particularly for developing countries, involves topical, self-administered products known as microbicides. The development of microbicides is a long and complicated process, and this volume provides an overview of all the critical areas, from the selection of appropriate candidate molecules and their formulation, preclinical and clinical testing for safety and efficacy, strategies for product registration and finally, issues associated with product launch, distribution and access. The book will prove valuable to both those working in the field and all others who are interested in learning more about this product class, which has the potential to significantly impact the future of this devastating epidemic.
Report
"This book offers a detailed review of essentially all aspects of microbicide development, from the basic science underlying microbicide action, to strategic considerations when implementing international microbicide programs. ... This text could be used as a primer for researchers entering the burgeoning field of microbicide development or for clinicians who provide these agents." (Douglas S. Krakower, Clinical Infectious Diseases CID, Vol. 60, June, 2015)
