BIOLOGICAL TESTING FACILITY - PRECLINICAL DEVELOPMENT OF CONTRACEPTIVES

Sri International, Menlo Park CA

Investigators

Abstract

The task will support all safety and efficacy studies of contraceptives in animal or in vitro models, using either in house or appropriate subcontract facilities as described in the Background. For products selected by the COR, the task order will demonstrate safety and efficacy of contraceptives in order to determine if the product is suitable for clinical evaluation. Since products can be delivered by a number of routes, including injectable, implant, oral, transdermal, intravaginal and intrauterine formulations, models utilized must be able to assess the safety of any or all of the possible routes. Reports describing effectiveness, safety or toxicity of appropriate doses and routes of administration are required for each study. In studies that are intended to be submitted as part of an IND, specific studies must be performed under Good Laboratory Practices (GLP). Reports of these studies must comply with all regulatory requirements and include sufficient documentation to allow the FDA to review and approve the proposed protocol that the safety package is designed to support. Assistance in preparing and filing an IND may be required, particularly for agents that are progressing from pre-clinical to first-in-human studies.