Bioequivalence and Bioavailability Forum • excluded period(s)

excluded period(s) [Regulatives / Guidelines]

posted by rajasekharkakarla – India, 2019-09-20 09:57 (2060 d 18:17 ago) – Posting: # 20630
Views: 5,766

Hi Helmut sir!

❝ Since according to the FDA a partial replicate has to be analyzed by SAS Proc GLM (or similar) IMHO all data of the subject will be dropped from the analysis (even if you observe a pre-dose concentration in just one period).

if we get the Swr less than 0.294 then we need to go for ABE approach in that can can we include those subjects in ABE calculation if subject completed 1 test and 1 reference treatment period.

what about in case of fully replicated designs, if we got the 5 % cmax in 4th period with 2 reference periods completed or one Test and Reference treatment period completed.

please help me..

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% 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