SYNTHESIS OF BULK CHEMICALS & DRUGS FOR PRECLINICAL USE

大宗化学品的合成

• 批准号: 6091054
• 负责人: JACK J PARSONS
• 金额: $ 97.63万
• 依托单位: STARKS ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-06-29 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6091054
• 关键词: antiAIDS agent; antineoplastics; chemical registry /resource; drug design /synthesis /production; drug quality /standard

The Pharmaceuticals Resources Branch (PRB) of the Developmental Therapeutics Program (DTP) of the Division of Cancer Treatment, Diagnosis and Chemotherapy (DCTDC) of the National Cancer Institute has primary responsibility for the production of a variety of compounds as bulk pharmaceuticals for use in both clinical and preclinical evaluations as potential anti-AIDS agents and anticancer agents. The PRB works closely with the DTP screening group to prepare larger quantities of drug candidates for in vivo evaluation and for the preparation of derivatives of drug candidates with improved physical properties, such as improved solubility or better pharmacokinetic properties, through the use of pro-drugs or other selected chemical derivatives. As part of this process, the PRB may undertake the development of existing or new, more efficient, chemical processes, procedures, and techniques for the preparation of those compounds of interest. Once identified as a potential drug candidate for anti-AIDS or anticancer treatment, the PRB undertakes the scale-up preparation of varying amounts of compound, based on the immediate needs of the program. The amounts may range from milligram quantities to multi-kilogram quantities, depending upon the stage of development of the compound and its biological potency. Once accepted for human clinical trials, the PRB is responsible for the preparation of clinical materials that meet the FDA requirements for Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) drug production. As such the procedures developed by PRB will define the purity standards and criteria for the clinical bulk pharmaceutical based on those produced during the scale-up process. The purpose of this project is to obtain contractors who have the equipment and expertise to conduct organic synthesis and purification of potential anti-AIDS and anticancer drug candidates in quantities up to multi-kilogram amounts. Further, they must be capable of production under GMP and GLP conditions when needed. They will be called upon to procure, purify (if necessary) and characterize substances from suitable sources; perform preliminary stability, solubility, and analytical studies on the products; and prepare analytical reference standards, and novel derivatives as needed by the program.

发展中国家药物资源分支（PRB） 癌症治疗和诊断部治疗学计划（DTP） 国家癌症研究所的化疗（DCTDC）具有主要的 负责生产各种散装化合物 用于临床和临床前评价的药物， 潜在的抗艾滋病剂和抗癌剂。 PRB与DTP筛选组密切合作， 用于体内评价和用于体内评价的候选药物的量 具有改善的物理性质的候选药物衍生物的制备 性质，例如改善的溶解度或更好的药代动力学 通过使用前药或其他选定的化学品， 衍生物.作为这一进程的一部分，审查委员会可采取下列行动： 开发现有的或新的更有效的化学工艺， 制备这些化合物的程序和技术 兴趣 一旦被确定为抗艾滋病或抗癌的潜在候选药物 治疗，PRB承担了不同数量的放大制备 的化合物，根据该计划的迫切需要。这些数额可能 范围从毫克数量到数公斤数量，取决于 根据化合物的开发阶段及其生物学效力。 一旦接受人体临床试验，PRB负责 准备符合FDA要求的临床材料， 药品生产规范（GMP）和药物非临床研究质量管理规范（GLP） 生产因此，PRB制定的程序将定义 临床原料药的纯度标准和规范 在扩大规模的过程中产生的。 该项目的目的是获得承包商谁拥有 设备和专业知识进行有机合成和纯化 潜在的抗艾滋病和抗癌候选药物，数量高达 几公斤的量。此外，它们必须能够在 GMP和GLP条件（如需要）。 他们将被要求 从合适的材料中采购、纯化（如有必要）和表征物质 来源;进行初步稳定性、溶解度和分析 对产品进行研究;并制备分析参比标准品，以及 新的衍生产品所需要的程序。