Bioequivalence and Bioavailability Forum • 0 hr Pre-dose concentration but less than 5% of Cmax

0 hr Pre-dose concentration but less than 5% of Cmax [Regulatives / Guidelines]

posted by jag009 – NJ, 2012-03-29 21:34 (4408 d 12:04 ago) – Posting: # 8349
Views: 10,629

Hi everyone,

Regarding the FDA guidance on pre-dose concentration:

"If the predose concentration is less than or equal to 5 percent of Cmax value in that subject, the subjects data without any adjustments can be included in all pharmacokinetic measurements and calculations. If the predose value is greater than 5 percent of Cmax, the subject should be dropped from all BE study evaluations."

What if a subject has a pre-dose concentration in period 1? Should the subject still be kept or needs to be removed since he shouldn't have any pre-dose concentration in period 1.

Clinic shows no deviations and data was reviewed.

Thanks

John

Complete thread:

0 hr Pre-dose concentration but less than 5% of Cmaxjag009 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% 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