BIOLOGICAL TESTING FACILITY - FORMULATION, SUPPLY, AND STABILITY TESTING OF CONTRACEPTIVE DRUG CANDIDATES FOR CLINICAL TESTING

生物测试设施 - 用于临床测试的候选避孕药物的配方、供应和稳定性测试

• 批准号: 9147745
• 负责人: KATHRYN BAUGHMAN
• 金额: $ 174.5万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-21 至 2016-09-20
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9147745
• 关键词: Animals; Biological Assay; Biological Testing; Clinical; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive Devices; Development; Devices; Dosage Forms; Dose; Drug Formulations; Drug Kinetics; Endocrine; Enrollment; Evaluation; Excretory function; Gel; Housing; In Vitro; Injection of therapeutic agent; Investigational Drugs; Investigational New Drug Application; Metabolism; Nestorone; Oils; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Placebos; Powder dose form; Preparation; Process; Quality Control; Research Personnel; Route; Safety; Services; Shipping; Ships; Skin; Solutions; Steroids; System; Testing; Testosterone; Toxic effect; Validation; Work; absorption; analytical method; capsule; chemical synthesis; clinical lot; contraceptive effectiveness; design; dosage; drug candidate; human subject; in vivo; lot production; pre-clinical; preclinical evaluation; product development; research clinical testing; stability testing

The Biological Testing Facility (BTF) is designed to permit rapid evaluation of new compositions of matter, drug formulations, delivery systems, and devices for contraceptive and endocrine activity. The BTF has the capability of formulation, clinical batch preparation and release and continued stability testing of drugs that are evaluated in clinical trials. 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 pharmacokinetic (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 provided or formulated by the BTF for clinical or IND enabling evaluation are prepared under Good Manufacturing Practices (GMP) to allow clinical evaluation in the CDDB Contraceptive Clinical Trials Network (CCTN). 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 as described in the Background but not limited to supply and/or formulation services designed to develop NCEs/APIs, for preclinical or clinical evaluation, in appropriate vehicles and appropriate concentrations that will be suitable for use as a contraceptive product. The agents may be developed in house or via appropriate subcontract facilities. Formulations may be administered orally, intramuscularly, transdermally or other routes of administration acceptable for clinical trials. The formulated products will be characterized with respect to pharmacokinetics, in vivo activity, safety, stability and other preclinical evaluations pursuant to filing and maintaining an IND that would support batch release and testing in clinical trials.

生物试验设施（BTF）的目的是允许快速评估新的物质组合物，药物配方，输送系统和避孕和内分泌活动的装置。BTF具有对临床试验中评价的药物进行处方、临床批制备和放行以及持续稳定性测试的能力。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提供或配制的用于临床或IND使能评价的化合物是根据良好生产规范（GMP）制备的，以允许在CDDB避孕临床试验网络（CCTN）中进行临床评价。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。 该任务将支持背景中所述的所有临床前活动，但不限于旨在开发用于临床前或临床评价的NCE/API的供应和/或配制服务，这些NCE/API采用适合用作避孕产品的适当载体和适当浓度。代理人可以在内部或通过适当的研究机构开发。制剂可以口服、肌内、透皮或临床试验可接受的其他给药途径给药。根据IND的备案和维护，将对配制产品的药代动力学、体内活性、安全性、稳定性和其他临床前评价进行表征，以支持批次放行和临床试验中的检测。