对于稳定性数据，临床期间其首要目的是支持临床给药。
对于生物制品，加速稳定性是不能用来支持外推产品的有效期，而必须依赖于实时的长期稳定性数据来支持有效期的设定。
因此，关注点应该是（1）在拟用于试验用药批次之前是否又一个“前置”的批次来提供稳定性数据，以支持临床用药？（这个前置批次的稳定性数据更多，能够覆盖到临床批次使用时的时间周期。你不能“用自己来证明自己稳定”，因为今天的稳定性数据只能说明你在今天之前稳定，下一秒你就没有数据支持了）（2）加速稳定性是否观察到显著变化，这个变化趋势与变更之前稳定性变化趋势一致？如果不一致，FDA可能会要求你提供更久的长稳数据。
如果以上都没有问题，我认为FDA hold的可能性很小。
附上一些法规参考：
21 CFR 312.23(a)(7)(ii)
It should be emphasized that the amount of information to be submitted depends upon the scope of the proposed clinical investigation. For example, although stability data are required in all phases of the IND to demonstrate that the new drug substance and drug product are within acceptable chemical and physical limits for the planned duration of the proposed clinical investigation, if very short-term tests are proposed, the supporting stability data can be correspondingly limited.
USP 〈1045〉 Biotechnology-Derived Articles
The use of accelerated stability studies to predict the shelf life of protein formulations is often complicated by the effects of temperature on protein conformation, resulting in non-Arrhenius behavior. Thus, reliance on real-time, recommended storage condition stability studies is often required for establishing the expiration dating of biotechnology-derived products.
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