SUPPORT PROGRAM OBJECTIVES OF DRUG SYNTHESIS AND CHEMISTRY BRANCH

药物合成与化学分会支持计划目标

• 批准号: 8882156
• 负责人: DAVID STARKS
• 金额: $ 51.55万
• 依托单位: STARKS ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-20 至 2016-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8882156
• 关键词: Air Pollutants; Carbon; Chemicals; Contractor; Contracts; Data; Development; Drug or Chemical; Ensure; Government; Health; High Pressure Liquid Chromatography; Instruction; Kilogram; Laboratories; Lead; Legal patent; Manufacturer Name; Marketing; Methodology; Methods; Nature; Peptides; Performance; Pharmaceutical Preparations; Preparation; Procedures; Process; Production; Protons; Reaction; Reference Standards; Regulation; Research; Residual state; Safety; Sampling; Solubility; Solvents; Source; Standard Preparations; Time; Transportation; United States Environmental Protection Agency; United States Occupational Safety and Health Administration; Water Pollutants; Work; Writing; base; cost; drug synthesis; interest; large scale production; literature citation; manufacturing process; meetings; melting; process optimization; programs; repository; research and development; safety study; scale up; small molecule; technical report

The overall objective is for the preparation of bulk chemicals/drugs that are needed by the NExT and other programs. The required materials are not readily available in the quality or quantities needed from the original supplier or on the open market. Major aspects of the contract work scope will include: (1) GMP process development to transform a laboratory scale to larger scale production ; (2) synthesis of bulk chemicals/drugs on multi-grams to multi-kilograms scale as needed; (3) analysis for ensuring the purity, identity and quality of the prepared compounds including QA/QC for the GMP batches; and (4) additional studies such as solubility/stability when required. Technical reports submitted by the Contractors may be used to support IND applications to the FDA.

总体目标是准备下一个和其他计划所需的散装化学药品/药物。原始供应商或公开市场所需的质量或数量不容易获得所需的材料。 合同工作范围的主要方面将包括：（1）GMP流程开发将实验室规模转化为更大规模的生产； （2）根据需要，将多克化学物质/药物合成到多克尔图量表上； （3）分析用于确保GMP批次的纯度，质量和质量的纯度，身份和质量； （4）需要的其他研究，例如溶解度/稳定性。承包商提交的技术报告可用于支持FDA的IND申请。