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Clinical evaluation of microbicide formulations
Kathleen M Morrow1, Craig Hendrix
1The Miriam Hospital and The Warren Alpert Medical School of Brown University, CBPM, Coro West, 1 Hoppin Street, Providence, RI 02903, USA. kmorrow@lifespan.org
Abstract:
The clinical evaluation of microbicide formulations presents variable and interacting challenges. Specific domains of acceptability, pharmacokinetics, and toxicity interact with each other to potentially inhibit or enhance a microbicide's efficacy. Each of these is further influenced by application and use parameters in the relative presence (or absence) of vaginal and/or seminal fluids, ultimately impacting effectiveness. Historically, acceptability of formulation and use parameters, and their concomitant behavioral influences, have been considered separately from pharmacokinetics and toxicity. While independent evaluation of these elements is necessary in some respects, we must acknowledge that this approach is not sufficient for the successful development of microbicides. Each needs to be considered in an integrated clinical evaluation strategy. This article presents the rationale for such an approach. This article forms part of a special supplement covering two presentations on clinical evaluation of microbicides from the symposium on "Recent Trends in Microbicide Formulations" held on 25 and 26 January 2010, Arlington, VA.
Insights
Developing effective microbicides requires an integrated clinical evaluation strategy. Acceptability, pharmacokinetics, and toxicity must be assessed together with formulation and use parameters for enhanced microbicide development.
Area of Science:
- Reproductive Health
- Infectious Disease Prevention
- Clinical Pharmacology
Background:
- Clinical evaluation of microbicide formulations faces complex, interacting challenges.
- Factors like acceptability, pharmacokinetics, and toxicity influence microbicide efficacy.
- These factors are affected by application methods and the presence of bodily fluids.
Purpose of the Study:
- To present the rationale for an integrated clinical evaluation strategy for microbicide development.
- To highlight the interconnectedness of formulation, acceptability, pharmacokinetics, and toxicity.
- To emphasize the limitations of evaluating these domains independently.
Main Methods:
- Review of existing challenges in microbicide clinical evaluation.
- Conceptual framework for an integrated approach.
- Discussion of interactions between formulation, pharmacokinetics, toxicity, and use parameters.
Main Results:
- Independent evaluation of microbicide domains is insufficient for successful development.
- An integrated strategy is necessary to address interacting challenges.
- Consideration of application and use parameters alongside biological factors is crucial.
Conclusions:
- An integrated clinical evaluation strategy is essential for advancing microbicide development.
- Holistic assessment of microbicide formulations is required for optimal effectiveness.
- Future research should focus on combined evaluation of all relevant domains.
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