Bioequivalence and Bioavailability Forum • CFDA: Draft guidance?

CFDA: Draft guidance? [RSABE / ABEL]

posted by libaiyi – China, 2018-06-13 05:39 (2142 d 13:05 ago) – Posting: # 18895
Views: 6,160

Thanks for you reply.

Another question,
how to write the null hypothesis and alternative hypothesis for BE based on FDA or EMA method?

Complete thread:

Calculate the BE limits for HVDPs based on EMA libaiyi 2018-06-08 11:41 [RSABE / ABEL]
- Calculate the BE limits for HVDPs based on EMA Shuanghe 2018-06-08 12:51
- (Expanded) BE limits, EMA-style Helmut 2018-06-08 13:19
  - (Expanded) BE limits, EMA-style libaiyi 2018-06-11 07:21
    - CFDA: Yet another story? Helmut 2018-06-11 12:24
      - CFDA: Yet another story? libaiyi 2018-06-12 11:09
        
        CFDA: Draft guidance? Helmut 2018-06-12 14:54
        
        CFDA: Draft guidance?libaiyi 2018-06-13 03:39
        
        Hypotheses generated “in face of the data” Helmut 2018-06-13 11:39
        
        Hypotheses generated “in face of the data” libaiyi 2018-06-14 03:46

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