Bioequivalence and Bioavailability Forum • Reanalysis if possible

Reanalysis if possible [Regulatives / Guidelines]

posted by jag009 – NJ, 2012-03-30 17:06 (4408 d 18:39 ago) – Posting: # 8354
Views: 9,575

Hi Helmut,

❝ OK, but if ever possible perform a reanalysis in duplicate. If the value was not too far away from the LLOQ it may have been pure chance as well.

Thanks. Yes the lab did reanalysis and came to the same conclusion (as per their SOP). It's just kind of strange to see value at 0 on period 1 that's all.

Have you seen CROs which go the full length and pre-screen subjects for exposure to the study drug prior to the first dosing day?

Thanks

John

Complete thread:

0 hr Pre-dose concentration but less than 5% of Cmax jag009 2012-03-29 19:34
- 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 possiblejag009 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% Cmax navoday 2012-08-15 20:37
        
        excluded period(s) Helmut 2012-08-16 16:36
        
        excluded period(s) rajasekharkakarla 2019-09-20 07:57