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BIOLOGICAL TESTING FACILITY - CLINICAL DEVELOPMENT AND FORMULATION OPTIMIZATION OF NEW PRODUCTS OR DEVICES FOR CONTRACEPTIVE METHODS

生物测试设施 - 用于避孕方法的新产品或装置的临床开发和配方优化

基本信息

批准号：
9360644
负责人：
KATHRYN BAUGHMAN
金额：
$ 139.79万
依托单位：
SRI INTERNATIONAL
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-26 至 2018-09-25
项目状态：
已结题

项目摘要

The objective of this task is to support preclinical and clinical formulation studies and GMP batch preparation of novel steroidal compounds or novel devices that can be evaluated in clinical trials pursuant to contraception studies in men or women. Appropriately formulated batches of drugs or devices are required for both clinical trials and for toxicology studies that are needed to demonstrate safety and efficacy of the products. Products have different formulation requirements and different pharmacodynamic properties when delivered orally, transdermally, vaginally, intrauterine or as an injectable agent. Thus, formulation studies need to be conducted to optimize the activity for the selected route of delivery. Multiple dosage forms of agents as well as placebos may be needed to be able to determine optimal efficacy in animals and human subjects. Studies may include development and validation of analytical methods associated with preparation of a clinical batch of product. For all clinical batches, manufacturing and quality control testing must be done under GMP (Good Manufacturing Practices) and preparation of appropriate regulatory documents must accompany any clinical batch that is released. Stability studies that support the clinical trials will be conducted for each clinical batch as is required for IND purposes. Drugs or devices must be stored under appropriate condition and shipped to designated clinical studies as directed by NICHD.

这项任务的目的是支持临床前和临床配方研究以及GMP批量制备新的类固醇化合物或新装置，这些化合物或装置可以根据男性或女性的避孕研究在临床试验中进行评估。临床试验和毒理学研究都需要适当配方的药物或装置，以证明产品的安全性和有效性。产品在口服、经皮、阴道、宫内或作为注射剂时，具有不同的配方要求和不同的药效学特性。因此，需要进行配方研究，以优化选定的交付路线的活动。可能需要多种剂型的制剂以及安慰剂才能确定对动物和人类受试者的最佳疗效。研究可能包括开发和验证与临床批次产品制备相关的分析方法。对于所有临床批次，必须根据GMP(良好制造规范)进行制造和质量控制测试，并且必须为发布的任何临床批次准备适当的法规文件。支持临床试验的稳定性研究将按照IND的要求对每个临床批次进行。药物或设备必须在适当的条件下储存，并按照NICHD的指示运往指定的临床研究。