Bioequivalence and Bioavailability Forum

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

posted by Helmut  – Vienna, Austria, 2012-04-05 20:08 (5191 d 11:09 ago) – Posting: # 8390
Views: 12,803

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 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”…)

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


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Science Quotes

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 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