Bioequivalence and Bioavailability Forum

Calculate the BE limits for HVDPs based on EMA [RSABE / ABEL]

posted by libaiyi – China, 2018-06-08 13:41 (2141 d 12:12 ago) – Posting: # 18870
Views: 7,267

Hi,

I am so confused about how to calculate the suitable BE limits for HVDPs based on EMA criterion since the range changes all the time.

When we get a CVwr, how to get the BE limits?

Thanks in advance

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Edit: Category changed; see also this post #1. [Helmut]

Complete thread:

• Calculate the BE limits for HVDPs based on EMAlibaiyi 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          • CFDA: Draft guidance?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            • CFDA: Draft guidance?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