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

本任务的目的是支持新型甾体化合物或新型器械的临床前和临床制剂研究以及GMP批次制备，这些新型甾体化合物或新型器械可根据男性或女性避孕研究在临床试验中进行评价。临床试验和毒理学研究都需要适当配制的药物或器械批次，以证明产品的安全性和有效性。当口服、透皮、阴道、子宫内或作为注射剂给药时，产品具有不同的制剂要求和不同的药效学特性。因此，需要进行制剂研究，以优化所选递送途径的活性。可能需要多种剂型的药剂以及安慰剂，以能够确定在动物和人类受试者中的最佳功效。研究可能包括与临床批次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，必须根据GMP（药品生产质量管理规范）进行生产和质量控制检测，并且放行的任何临床批次必须随附适当的监管文件。根据IND的要求，将对每个临床批次进行支持临床试验的稳定性研究。药物或器械必须储存在适当的条件下，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.