SYNTHESIS OF COMPOUNDS FOR PRECLINICAL TOXICOLOGY

用于临床前毒理学的化合物的合成

• 批准号: 3614223
• 负责人: YASHWANT S KULKARNI
• 金额: $ 26.46万
• 依托单位: ALDRICH CHEMICAL COMPANY
• 依托单位国家: 美国
• 财政年份: 1986
• 资助国家: 美国
• 起止时间: 1986-09-30 至 1991-03-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3614223
• 关键词: analytical method; bioassay; chemical synthesis; drug adverse effect; drug design /synthesis /production; drug metabolism; drug quality /standard; neoplasm /cancer pharmacology

The general objective of the project is to synthesize a variety of medicinal compounds which have been identified by the Developmental Therapeutics Program for development, preclinical toxicology and phase 1 clinical trial. These compounds are not readily available in the quality and quantity needed from the original supplier or on the open market. The laboratories are used to obtain data for the preparation of the necessary quantities of clinically important chemicals and to develop the most economical means for their preparation. Many methods of synthesis which are practical for small quantities are not technically feasible or economically practical when used for large-scale synthesis operation. The conversion of small-scale production often requires development work which is carried out by these contractors. The preparation laboratories provide the means of obtaining nearly any type of chemical compound in large quantities. The materials are of very high purity and are well characterized. The quantity of a given material synthesized may range from fifty grams to 5 kilograms. Factors governing the amounts needed include the rate of usage, ease of preparation, chemical stability, and cost. Compounds received from these contractors are prepared under current Good Manufacturing Practices and are intended for Preclinical Toxicology, and Phase I Clinical Studies.

该项目的总体目标是合成各种 已被开发鉴定的药用化合物 开发、临床前毒理学和第一阶段的治疗方案 临床试验。这些化合物在这种质量上不容易买到 以及从原始供应商或在公开市场上所需的数量。 这些实验室被用来获得数据，用于准备 必要数量的临床重要化学物质，并开发 最经济的方法来准备它们。多种合成方法 对于小批量是可行的，在技术上是不可行的，或者 用于大规模合成操作时，经济实用。这个 小规模生产的转换往往需要开发工作，这一工作 是由这些承包商进行的。准备实验室提供 获得几乎任何类型化合物的方法 数量。这些材料的纯度很高，而且很好 特色化的。合成的特定材料的量可在以下范围内 50克到5公斤。控制所需数量的因素包括 使用率、制备简易性、化学稳定性和成本。 从这些承包商收到的化合物是在Current Good项下制备的 生产实践，用于临床前毒理学，以及 第一阶段临床研究。