Bioequivalence and Bioavailability Forum

CFDA: Yet another story? [RSABE / ABEL]

posted by libaiyi – China, 2018-06-12 13:09 (2527 d 02:46 ago) – Posting: # 18887
Views: 7,571

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CFDA has relased the draft guidance for HVBE, which follows FDA method (RSABE).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

Complete thread:

• Calculate the BE limits for HVDPs based on EMA libaiyi 2018-06-08 11:41 
  • 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          • CFDA: Draft guidance?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            • CFDA: Draft guidance?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