BIOLOGICAL TESTING FACILITY - PRECLINICAL DEVELOPMENT OF CONTRACEPTIVES

NICHD支持研究开发可能扰乱正常排卵、精子产生或精子功能的化合物，以便为男性或女性开发安全、有效和廉价的避孕药。生物检测设施的设计是为了能够快速评估新的物质成分、药物配方、给药系统以及避孕和内分泌活动的装置。BTF提供全面的项目管理和能力，以支持临床前活动的所有阶段和避孕药的开发：这些包括但不限于体外和体内分析、吸收、分布、代谢、排泄和毒性(ADMET)和药代动力学(PK)分析、动物活动和研究、活性药物成分(API)的制造、工艺和产品开发、配方、临床批量生产、临床前使能研究和导致研究新药(IND)申请备案的相关任务。由BTF配制的化合物是根据良好制造规范(GMP)制备的，以便在CDDB避孕临床试验网络(CCTN)中进行临床评估。CCTN的调查人员已经准备了方案和任务，正在授予或正在授予CCTN站点进行临床试验。BTF一直在与CORS(化学合成设施和CCTN)和CCTN的调查人员合作，为临床批次开发和测试适当的配方。每种候选药物的下一步研究都依赖于及时收到临床批次来开始招募和招募过程。目前正在进行临床试验的药物需要对临床配方进行稳定性测试。 该任务将支持所有临床前活动，包括但不限于新化学物质(NCEs)和/或活性药物成分(API)在适当载体中的体内和体外分析、有效性、安全性和毒理学，以及适合用作避孕产品的适当浓度的内部或适当分包设施。这些药物可以口服、肌肉注射、经皮给药或其他临床材料可接受的给药途径。根据支持临床试验测试的IND的申请，配制的产品应在适合给药途径和活动持续时间的所有区域和物种中进行体内安全性和毒理学表征。

NICHD has supported research to develop compounds that can disrupt normal ovulation, sperm production or sperm function so that safe, effective and inexpensive contraceptives can be developed for men or women. The Biological Testing Facility is designed to permit rapid evaluation of new compositions of matter, drug formulations, delivery systems, and devices for contraceptive and endocrine activity. The BTF provides overall project management and the capabilities to support all phases of preclinical activities and development of contraceptives: these are but not limited to in vitro and in vivo assays, absorption, distribution, metabolism, excretion and toxicity (ADMET) and pharmacokinetics (PK) 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 the filing of investigational new drug (IND) applications. Compounds formulated by the BTF are prepared under Good Manufacturing Practices (GMP) to allow clinical evaluation in the CDDB Contraceptive Clinical Trials Network (CCTN). The CCTN investigators have prepared the protocols and tasks are awarded or in the process of award to the CCTN sites to conduct the clinical trials. The BTF has been working with the CORs (for the Chemical Synthesis Facility and the CCTN) and the investigators in the CCTN to develop and test the appropriate formulations for clinical batches. The next study for each candidate drug is dependent on timely receipt of clinical batches to begin the process of recruitment and enrollment. Drugs that are currently in ongoing clinical trials require stability testing of the clinical formulations. The task will support all preclinical activities using either in house or appropriate subcontract facilities as described in the Background including but not limited to in vivo and in vitro assay, efficacy, safety and toxicology of new chemical entities (NCEs) and or active pharmaceutical ingredients (API) in appropriate vehicles and appropriate concentrations that will be suitable for use as a contraceptive product. The agents may be administered orally, intramuscularly, transdermally or other routes of administration that are acceptable for clinical materials. The formulated products shall be characterized for in vivo safety and toxicology in all areas and species that would be appropriate to the route of administration and duration of activity pursuant to filing an IND that would support testing in clinical trials.