DEVELOPMENT AND MANUFACTURE OF DOSAGE FORMS OF COMPOUNDS

获得性免疫缺陷综合征(AIDS)与 美国国立卫生研究院微生物学与传染病项目 过敏症和传染病组织积极参与各项计划，以： 开展传染病过程的基础调查，以及 发现治疗这些疾病的新的治疗方法 国家合作药物发现小组机制与筛选 程序。这些疗法针对的是各种传染性疾病。 疾病包括由艾滋病毒、巨细胞病毒、疱疹引起的疾病 单纯性肺炎、肺孢子虫肺炎、白色念珠菌、禽分枝杆菌 NIAID资助的药物发现中的一些，但不是全部 机制有能力和能力执行所需的 体外预测转化具有活性的化合物的研究 将测试系统或动物模型转换为药物剂型 以足够的规模制造，以允许I期和II期临床 对物质的评价。这一倡议提供了以下能力 研制以下剂型：无菌冻干、无菌液体、 胶囊、片剂制剂和生产规模足以满足 准备4000瓶(每年2批)的批量；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要求的质量控制测试 并确定这些制剂在模拟条件下的稳定性 使用条件。这些研究将按照食品标准进行 和药品监督管理局现行的良好生产规范 法规。

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.