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•交换问答1.3和1.4的顺序以提供更合乎逻辑的顺序•在问答2.1中，对ICH Q11进行了指定，以定义半合成药物物质和产品•在Q＆A 7.2和7.3中，其他解释是为何不足以将In Vivo突变数据添加到足够的情况下，以设置复杂性的含量。However, the Q&A enables the use of in vivo assay results to complement available data for a weight of evidence approach to support a higher limit on a case by case basis • In Q&A 8.1 conditions for using option 4 control strategies are explained in more detail • Q&A 8.3 was reworded to provide more clarity on expectations for control approaches of impurities introduced in the last synthetic step • In Q&A 9.2 additional specific references are added for recommendations on content ICH M7风险评估和控制策略的CTD中的位置
m7（r2）ICH M7（R2）：DNA反应性的评估和控制（...ICH M7（R2）：DNA反应性的评估和控制（...
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