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

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

posted by Helmut – Vienna, Austria, 2012-04-05 18:08 (3580 d 11:43 ago) – Posting: # 8390
Views: 8,349

Hi John!

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

Can? Technically, yes. But I wouldn’t recommend it (see the [image]

2003 guidance):

If the predose concentration is ≤ 5 percent of C_max value in that subject, the subject’s data without any adjustments can be included in all pharmacokinetic measurements and calculations.

(my emphasis; interpreting “can” as “should”…)

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Helmut Schütz

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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% CmaxHelmut 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