A discussion on the regulatory chemistry, manufacturing, and control (CMC) strategy and the dialogue and response from global health authorities regarding the proposed impurity/degradant control strategy for two (2) accelerated oncology programs developed under the scope of ICH S9 is presented. While the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3A/Q3B requirements are generally not considered applicable for first-in-human or early phase drug substance and drug product specifications, understanding regulatory expectations relating to CMC control strategies for accelerated oncology programs remains challenging.

中文翻译：

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临床早期合成肿瘤学计划的控制策略预期：两个全球监管案例研究

讨论了关于化学控制，制造和控制（CMC）策略以及全球卫生当局针对在ICH S9范围内制定的两（2）个加速肿瘤学计划的杂质/降解物控制策略的对话和响应的讨论。虽然国际人用药品技术要求统一理事会（ICH）Q3A / Q3B要求通常不被认为适用于人用或早期阶段的原料药和药品规格，但请了解与CMC控制策略有关的监管要求加速肿瘤学计划仍然具有挑战性。