Bioequivalence and Bioavailability Forum • (Expanded) BE limits, EMA-style

(Expanded) BE limits, EMA-style [RSABE / ABEL]

posted by libaiyi – China, 2018-06-11 09:21 (2587 d 17:56 ago) – Posting: # 18881
Views: 7,671

Hi，

I want to know how to figure out that whether the results are bioequivalence?

According to CFDA (China Food and Drug Administration) guidelines, when CVwR of Cmax is larger than 0.3, BE limits are fixed at (69.83, 143.19). Can we use the results from Mixed Model by SAS directly to determine if it falls between the limits or not? :-D

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-stylelibaiyi 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        CFDA: Draft guidance?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        CFDA: Draft guidance?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