Bioequivalence and Bioavailability Forum • Purpose?

Purpose? [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2020-07-09 15:10 (2179 d 12:51 ago) – Posting: # 21664
Views: 8,645

Hi Mithu,

❝ :-) Actually sir when we receive PK data from site (CRO), we check by using Excel. That's why i was using Excel for verification. Generally in average BE and partial replicate, we get it verified but for fully replicate study, i could not match the ratio.

❝

❝ This is the story.

I don’t understand the purpose of this ‘verification’. Calculate the study in SAS. The individual T/R-ratios don’t play any role in RSABE (log-differences are only an intermediate result).
Are you concerned about extreme values? They are common for HVD(P)s.¹ Contrary to ABEL (used in all jurisdictions for reference-scaling except in the US and China) assessing ‘outliers’² is not acceptable for RSABE.

I have seen studies with subject ratios of 0.2–5 (‼) and still passing RSABE.
In ABEL of the reference treatment only.

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Complete thread:

Ratio calculation of fully replicate study Mithu 2020-07-09 09:18
- Ratio calculation of fully replicate study Helmut 2020-07-09 10:51
  - Ratio calculation of fully replicate study Mithu 2020-07-09 11:23
    - Ratio calculation of fully replicate study Helmut 2020-07-09 12:19
      - Ratio calculation of fully replicate study Mithu 2020-07-09 12:46
        
        Purpose?Helmut 2020-07-09 13:10
        
        Purpose? Mithu 2020-07-09 13:22
        
        Purpose? Helmut 2020-07-09 13:56
        
        Purpose? jag009 2020-07-09 18:01
        Purpose? Mithu 2020-07-10 08:00