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CFDA: Yet another story? [RSABE / ABEL]

posted by libaiyi - China, 2018-06-12 11:09  - Posting: # 18887
Views: 729

Hi Helmut,

thanks for your help.

CFDA has relased the draft guidance for HVBE, which follows FDA method (RSABE).

I still have a question about EMA method. Do you mean if we follow EMA's guidance, the ABEL should be used rather than RSABE, please give me more advise.

thanks in advance. :-D:-D:-D

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