DEVELOP PROGESTAGEN-CONTAINING MICROCAPSULES

合成3千克聚-L-（-）丙交酯RSV + 1.0（+，-）0.2 dl/g， 包封左炔诺孕酮。制备足量的微胶囊， 使用FDA规定的良好生产规范，用于 理化表征，动物临床前评价，以及 未来的临床研究 测定体外激素释放特性， 微胶囊的物理化学性质。 提供微胶囊， NICHD用于体内研究，以确定激素血液水平， 释放、剂量响应和再现性。向NICHD提供微胶囊， 评价微囊在动物体内的安全性。 提交IND申请 用于临床研究

Synthesize three kilograms of poly-L-(-)lactide RSV + 1.0 (+,-)0.2 dl/g for the encapsulation of levonorgestrel. Prepare sufficient quantity of microcapsules, using Good Manufacturing Practice as specified by the FDA, for use in physical-chemical characterization, preclinical evaluation in animals, and future clinical studies. Determine the in vitro hormone release properties and the physical-chemical properties of the microcapsules. Provide microcapsules to NICHD for in vivo studies to determine hormone blood levels, duration of release, dose response, and reproducibility. Provide microcapsules to NICHD to evaluate the safety of the microcapsules in animals. Submit application for IND to the FDA for clinical studies.