Bioequivalence and Bioavailability Forum • Purpose?

Purpose? [RSABE / ABEL]

posted by Mithu – India, 2020-07-10 10:00 (1821 d 09:36 ago) – Posting: # 21668
Views: 6,218

Dear Sir,

❝ ❝ ❝ 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.

❝

❝ What will you do (or have done in the past) with your ‘verification’? The T/R-ratios are not part of the RSABE SAS-output provided by the CRO.

First of all please accept my apology. My intention is not to ignoring your question. Actually i do not have any answer for it.

I do understand that ratio is not only part of SABE study passout. but this is the only tool which i could work out in excel. for 95% upper bound, i don't have any idea or knowledge to check in excel. Even i could also not able to calculate associate variability i.e. swr in tool like excel.

Learning form internet how to calculate PK and putting some efforts at my end.

I am learning statistics and when stuck rely on this forum for answer.

Again i am sorry if you still fell that i am ignoring your questions.

Regards,

Mithu.

Complete thread:

Ratio calculation of fully replicate study Mithu 2020-07-09 09:18 [RSABE / ABEL]
- 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