Bioequivalence and Bioavailability Forum • Purpose?

Purpose? [RSABE / ABEL]

posted by Mithu – India, 2020-07-09 15:22 (1378 d 16:06 ago) – Posting: # 21665
Views: 3,978

Dear Sir,

❝ 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. Contrary to ABEL (used in all jurisdictions for reference-scaling except in the US and China) assessing ‘outliers’ is not acceptable for RSABE.

Actually Sir, we do not have SAS at our end (sponsor) but now i got the point that such verification will not help in excel.

Actually at present i prepared excel for one of the our HVD and just learning how the data are interpreted.

Now i suggest my management to equipped us with proper tool to verify data correctly at our end.

CRO runs on SAS and providing PK sheet of data in excel to us and i was checking with excel. But today i got the correct way and understand how the software calculate ratio.

Regards,

Mithu.

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