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Published on: January 10, 2025
Pre-clinical and early clinical considerations for the development of non-hormonal contraceptives for men
1Contraception Research Branch, Fertility and Infertility Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA.
Introduction:
This manuscript presents non-hormonal male contraceptive development in the context of mitigating risk to investigators and investors.
Objective:
The manuscript uses examples to illustrate drug development principles to move a project from discovery to development. The content is intended for those with reproductive biology backgrounds without significant exposure to drug development-particularly early-stage targeted drug development-and those with general interest in developing non-hormonal methods of contraception.
Conclusion:
The goal of issues addressed in this manuscript is to facilitate the advancement of innovative male contraceptives into late-stage clinical trials, while keeping in mind early recognition of program deficiencies and development of mitigation strategies, or reassignment of limited, valuable resources.
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