DEVELOPMENT AND MANUFACTURE OF DOSAGE FORMS OF COMPOUNDS

获得性免疫缺陷综合症（艾滋病）司和 美国国立卫生研究院微生物学和传染病项目 过敏和传染病积极参与计划，以： 对传染病过程进行基本调查， 发现新的治疗方法来治疗这些条件，通过 国家合作药物发现小组机制和筛选 程序.这些疗法针对各种各样的传染性疾病， 疾病，包括由HIV、巨细胞病毒、疱疹 单纯性，肺孢子虫肺炎，白色念珠菌，鸟分枝杆菌 一些但不是所有的NIAID资助的药物发现 机制有能力和能力执行所要求的 研究将在体外预测中表现出活性的化学物质转化为 试验系统或动物模型转化为药物剂型 以足够的规模生产，以允许I期和II期临床试验 物质的评价。这一举措提供了以下能力： 开发以下剂型：无菌冻干、无菌液体， 胶囊和片剂制剂以及足以 制备批量为4000小瓶（每年2批）; 50，000片（2片） 每年一批）和50，000粒胶囊（每年一批）。承包商 将对所有制造的产品进行所需的质量控制测试， 并确定制剂在模拟条件下的稳定性。 使用条件这些研究将根据食品标准进行雅阁。 和药品管理局现行的药品生产质量管理规范 规定

The Division of Acquired Immune Deficiency Syndrome (AIDS) and the Microbiology and Infectious Disease Program of the National Institute of Allergy and Infectious Diseases are actively engaged in programs to: carry out basic investigations of the infectious disease process, and discover novel therapeutic approaches to treat these conditions via the National Cooperative Drug Discovery Group mechanism and screening programs. These therapies are directed at a wide variety of infectious diseases including those produced by HIV, cytomegalovirus, Herpes simplex, Pneumocystis pneumonia, Candida albicans, Mycobacterium avium complex, etc. Some but not all of the NIAID funded drug discovery mechanisms have the capability and capacity to carry out the required studies to convert chemicals exhibiting activity in a predictive in vitro test system or animal model into a pharmaceutical dosage form manufactured on sufficient scale to permit phase I and II clinical evaluation of the substance. This initiative provides the capability to develop the following dosage forms: sterile freeze dried, sterile liquid, capsule, and tablet formulations and a manufacturing scale adequate to prepare batch sizes of 4000 vials (2 lots annually); 50,000 tablets (two lots annually) and 50,000 capsules (one lot annually). The contractor will carry out the required quality control tests on all manufactured lots and also determine the stability of the formulations under simulated use conditions. These studies will be conducted in accord with the Food and Drug Administration's current Good Manufacturing Practice Regulations.