Bioequivalence and Bioavailability Forum • No correction if ≤5% Cmax

No correction if ≤5% Cmax [Regulatives / Guidelines]

posted by navoday – India, 2012-08-15 22:37 (5048 d 02:03 ago) – Posting: # 9070
Views: 12,150

❝ ❝ […] can the pre-dose (0 hr) concentration be set to 0 if it is less than 5% of Cmax? FDA that is...

Dear Helmut...

wishing you and all members of forum a very happy independence day (india)

should we submit statistical data with inclusion and exclusion of that subject having predose concentration more than 5% of C_max or simply delete that subject from all analysis? what if study is partial replicate (3WSABE)and that subject has completed TR sequence? as it may help for estimating t1/2 and tmax if average bioequivalence is there.

Complete thread:

0 hr Pre-dose concentration but less than 5% of Cmax jag009 2012-03-29 19:34 [Regulatives / Guidelines]
- 0 hr Pre-dose concentration but less than 5% of Cmax Helmut 2012-03-29 19:50
  - 0 hr Pre-dose concentration but less than 5% of Cmax jag009 2012-03-29 20:10
    - Reanalysis if possible Helmut 2012-03-29 23:17
      - Reanalysis if possible jag009 2012-03-30 15:06
        
        >6 sources of matrix Helmut 2012-03-30 15:16
        
        >6 sources of matrix jag009 2012-03-30 20:40
        
        >6 sources of matrix Helmut 2012-03-31 00:23
        
        >6 sources of matrix jag009 2012-04-04 16:32
        
        Flashback Helmut 2012-04-05 16:10
        
        Flashback jag009 2012-04-05 17:51
        
        No correction if ≤5% Cmax Helmut 2012-04-05 18:08
        
        No correction if ≤5% Cmaxnavoday 2012-08-15 20:37
        
        excluded period(s) Helmut 2012-08-16 16:36
        
        excluded period(s) rajasekharkakarla 2019-09-20 07:57