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

这项任务的目的是支持临床前和临床配方研究以及新型甾体化合物或新型器械的GMP批量制备，这些化合物或器械可以根据男性或女性避孕研究在临床试验中进行评估。临床试验和证明产品安全性和有效性的毒理学研究都需要适当配方的药品或器械批次。当口服、经皮、阴道、宫内或作为注射剂给药时，产品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，以优化所选择的递送途径的活性。可能需要多种剂量形式的药物以及安慰剂才能确定动物和人类受试者的最佳疗效。研究可能包括与临床批产品制备相关的分析方法的开发和验证。对于所有临床批次，生产和质量控制测试必须在GMP（良好生产规范）下进行，并且任何临床批次的发布都必须准备适当的法规文件。支持临床试验的稳定性研究将根据新药开发目的对每个临床批次进行。药物或器械必须在适当的条件下储存，并按照NICHD的指示运送到指定的临床研究。

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.