SYNTHESIS OF COMPOUNDS FOR PRECLINICAL TOXICOLOGY

该项目的总体目标是综合各种 已被开发部门鉴定的药用化合物 开发、临床前毒理学和I期治疗项目 临床试验 这些化合物在质量上不容易获得 以及从原始供应商或在公开市场上所需的数量。 这些实验室用于获取数据， 必要数量的临床重要化学品，并开发 最经济的方法来制备。 许多合成方法 对于小批量是实用的，但在技术上是不可行的， 当用于大规模合成操作时经济实用。 的 小规模生产的转型往往需要发展工作， 是由这些承包商进行的。 制备实验室提供 获得几乎任何类型的化合物的方法 是介于 这些材料具有非常高的纯度， 表征了 合成的给定材料的量可以在以下范围内 50克到5公斤。 决定所需数额的因素包括 使用率、制备容易性、化学稳定性和成本。 从这些承包商收到的化合物按照现行良好 生产规范，预期用于临床前毒理学，以及 I期临床研究。

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.