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vipjhy

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[求助] 进口质量标准与申报临床质量标准草案关于溶出度检查的规定

最近在做一个报产的项目，由于拿到临床批件据今时间比较久远，现在工艺验证处方溶出度测定符合申报临床质量标准草案的规定。但发现该申报临床质量标准草案溶出度的测定方法在转速上高于进口质量标准，取样时间长于进口质量标准。且发现用申报临床质量标准草案方法，对照制剂的溶出明显快于自制制剂的。我想问的是，是不是说明处方要做更改？另外，请问如何理解“一定要参考质量标准或进口注册标准，但不能迷信”？

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从头开始: 金币+5, 感谢参与 2012-11-03 08:19:06

请问如何理解“一定要参考质量标准或进口注册标准，但不能迷信”？
For your reference:
一定要参考质量标准或进口注册标准
This is a very helpful in vitro reference for your dissolution testing. If your drug showed the same in vitro dissolution profile by using the same dissolution method, at least you can start to try PK study. Otherwise you need optimize your formulation further.
但不能迷信
The most important is your drug human PK data. You need meet BE range. Therefore even your drug showed the same dissolution profile in vitro as brand drug by using 参考质量标准或进口注册标准, you may not have the same BE which means your drug also will have possibility to fail.
且发现用申报临床质量标准草案方法，对照制剂的溶出明显快于自制制剂的。我想问的是，是不是说明处方要做更改？
Most likely you will have different PK profile. If you are working on generic drug, it is better to improve your formulation to get the same dissolution profile as brand. If in this case, for my daily work, I will immediately modify my formulation to save your future time.