BIOLOGICAL TESTING FACILITY (BTF) - DEVELOPMENT OF CONTRACEPTIVE PRODUCTS INTENDED FOR NON-SYSTEMIC DELIVERY

点击翻译按钮获取中文摘要

The Contraception Research Branch (CRB) within the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) supports research to develop compounds that can disrupt oogenesis, spermatogenesis, normal ovulation, sperm maturation and/or function affording safe and effective contraceptives that can be implemented for men and/or women. The Biological Testing Facility (BTF) is designed to permit rapid evaluation of new compositions of matter, use cases for existing chemical matter, drug formulations, delivery systems, and devices for contraceptive and/or contraceptive-containing multipurpose prevention (cMPT) activity. The BTF provides overall project management and the capabilities to support all phases of nonclinical activities pursuant to development of new contraceptives methods. These capabilities include but are not limited to assays (in vitro, ex vivo and in vivo); plasma and microsomal stability studies; absorption, distribution, metabolism, excretion (ADME); toxicity; pharmacokinetic (PK) and pharmacodynamic (PD) profiling; animal activities and studies; manufacture of active pharmaceutical ingredients (APIs); process and product development; formulation; clinical lot production; preclinical enabling studies; and associated tasks leading to filing of investigational new drug (IND) or investigational device exemption (IDE) applications. The BTF has the capability to prepare compounds under current good manufacturing practices (cGMP) to allow clinical evaluation and conduct studies under current good laboratory practices (cGLP). The BTF plays a critical role in the product development mission of the CRB.