BIOLOGICAL TESTING FACILITY - PRECLINICAL DEVELOPMENT OF CONTRACEPTIVES

NICHD支持研究开发能够破坏正常排卵、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具。生物试验设施的目的是允许快速评价新的物质成分、药物配方、输送系统以及避孕和内分泌活性装置。BTF提供全面的项目管理和支持所有阶段的临床前活动和避孕药开发的能力：这些是但不限于体外和体内测定、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、制剂，临床批量生产、临床前使能研究和相关任务，从而提交研究性新药（IND）申请。由BTF配制的化合物根据良好生产规范（GMP）制备，以允许在CDDB避孕临床试验网络（CCTN）中进行临床评价。CCTN研究者已准备好方案，并已授予或正在授予CCTN研究中心进行临床试验的任务。BTF一直在与COR（化学合成机构和CCTN）和CCTN的研究者合作，开发和检测临床批次的适当制剂。每种候选药物的下一项研究取决于是否及时收到临床批次，以开始招募和入组过程。目前正在进行临床试验的药物需要进行临床制剂的稳定性试验。 该任务将支持使用内部或适当的实验室设施进行的所有临床前活动，如背景中所述，包括但不限于适用于避孕产品的适当溶剂和适当浓度的新化学实体（NCE）和/或活性药物成分（API）的体内和体外试验、疗效、安全性和毒理学。所述药剂可以口服、肌内、透皮或临床材料可接受的其他给药途径给药。应根据支持临床试验检测的IND申请，对配制产品在所有区域和种属中的体内安全性和毒理学进行表征，这些区域和种属适用于给药途径和活性持续时间。

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.