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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。
The FDA’s CDER issued the Guidance for Industry Reproductive and Developmental Toxicities -Intertribution Study Results to Assess Concerns in September 2011. This guideline comprehensively expounds the information needed for comprehensive analysis and assessment, the type of assessment of reproductive and developmental toxicity, the comprehensive analysis and evaluation procedures, and focuses on the decision-making process for comprehensive analysis and evaluation. This guideline is of great significance for instructing researchers on the comprehensive evaluation of non-clinical genotoxicity of drugs. The original text of the comprehensive analysis and assessment process is extracted for reference by researchers.