生殖与发育毒性——研究结果综合评价相关性指导原则(英文)

美国FDA的CDER于2011年9月颁布了《生殖与发育毒性--研究结果综合评价相关性指导原则》(Guidance for Industry Reproductive and Developmental Toxicities-Integrating Study Results to Assess Concerns)。该指导原则全面地阐述了综合分析及评估所需资料、生殖与发育毒性评估的类型、综合分析与评价程序,其中重点阐述了综合分析与评价的决策过程。该指导原则对于指导研究者进行药物非临床生殖毒性综合评价具有重要意义,现摘录综合分析与评估过程部分原文,以供研究者参考。

III. THE INTEGRATION AND ASSESSMENT PROCESS

Recommendations for wording in labeling should be based on the results of the integration and assessment process. The specific considerations leading to a risk conclusion should be provided.This information may later be helpful in discussions between FDA reviewers and aoolicants.