Bioequivalence and Bioavailability Forum

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

posted by Shuanghe  – Spain, 2018-06-08 14:51 (2288 d 16:57 ago) – Posting: # 18872
Views: 7,076

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?

The easiest way is using R. Some nice guy in this forum wrote a package so basically
library(powerTOST)
scABEL(CV, regulator)
will give you whatever you want, where CV is the CV of reference. And it's not limited to EMA. you can use it for calculations according to US FDA's and Canadian's guidance too (regulator="FDA" or "HC"). e.g.

scABEL(0.5, regulator="EMA") will give you
    lower     upper
0.6983678 1.4319102

and scABEL(0.4, regulator="EMA") will give
    lower     upper
0.746177 1.340165

If you like to reinventing the wheel then it is also pretty straightforward to do so. If your CV_WR is between 30% and 50%, the lower and upper limit is EXP(-0.76*sWR) and EXP(0.76*sWR), respectively.
Relatioship between CV_WR and s_WR is described in EMA's guideline. you can check the formula there.

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 EMAShuanghe 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          • CFDA: Draft guidance?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            • CFDA: Draft guidance?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