建议：注册3批+BE批都开展并和RLD比较

依据：

溶出曲线：依据：应在不同酒精浓度的介质中对MR制剂最低规格和最高规格进行药物释放的体外评价。在体外评估MR制剂乙醇诱导的剂量倾泻时，可采用溶出曲线。需得出完整的溶出曲线，且应比较溶出曲线的形状并使用F2因子评估溶出曲线之间相似性（或缺乏相似性）

QbD示例 缓释制剂 2.2.1.3 ER Bead Formulation Development：An in vitro alcohol-induced dose dumping study was conducted using 0.1 N HCl with 5%, 20% and 40% (v/v) of Alcohol USP. Data was collected every 15 minutes for a total of two hours. The ER coated beads performed similarly to the RLD tablets under each condition (data included in Module 5). The study also investigated if Kollicoat SR 30 D aging or lot-to-lot variability impacted alcohol-induced dose dumping and concluded that, for this formulation, these variables played an insignificant role in susceptibility to alcohol-induced dose dumping.

CDE 以药动学参数为终点评价指标的化学药物仿制药人体生物等效性研究技术指导原则 

思考：虽然各指南只提及了研究浓度、规格，未明确批次，但通常溶出曲线的批间差异已有一定的要求，批间的一致性也是可以侧面说明工艺的稳健性等。