Bioequivalence and Bioavailability Forum

excluded period(s) [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2012-08-16 18:36 (4264 d 23:12 ago) – Posting: # 9073
Views: 8,850

Hi Navoday!

❝ 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?

Even complying with the guidance I always state the planned procedure in the protocol. I report the PK data (in order to give the assessor a mean to check them) but exclude the subject in a 2×2 cross-over from comparative assessments. If the pre-dose concentration is observed not in all periods and the study is either a replicate or a higher-order cross-over, I proceed as following:

• Replicate: Keep the data if at least one period after test and reference is available and the study is analyzed by mixed effects model.
  
• Higher-order (e.g., one tests and two references): If the pre-dose concentration is observed after one of the references, keep the other data.

❝ 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.

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).

❝ as it may help for estimating t1/2 and tmax if average bioequivalence is there.

Don’t understand what you mean here.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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