Bioequivalence and Bioavailability Forum

The EMA’s Cmin & WinNonlin [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2010-03-13 13:52 (5577 d 04:17 ago) – Posting: # 4912
Views: 23,997

Dear Ravi!

❝ Now my question is Which definition is to be followed.

The one you have stated in your approved protocol.
See this little survey.

❝ If definition by EMEA is to be followed then we can not use Cmin value calculated by using WinNonlin for submission.

Since Cmin in WinNonlin is always the true (=global) minimum within τ, you have to improvise. If all your concentrations at t=τ are ≥LLOQ, use Clast instead. If not, use the same set of rules you would use for values <LLOQ. Describe the procedure in an SOP and – even better – in the protocol.

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


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Complete thread:

• EMA BE guideline - final version Ohlbe 2010-01-28 18:31 [Regulatives / Guidelines] 
  • Final version published Helmut 2010-01-29 14:29
    • Final version published ElMaestro 2010-01-29 17:02
      • Statistix Helmut 2010-01-29 17:30
        • Statistix ElMaestro 2010-01-29 18:11
      • Calories ;-) Helmut 2010-01-29 19:22
        • Calories ;-) ElMaestro 2010-01-29 20:43
          • Calories ;-) Helmut 2010-01-29 21:08
        • Variable calories d_labes 2010-02-01 12:05
      • ANOVA only - no doubts Helmut 2010-02-10 23:41
        • ANOVA only - no doubts ElMaestro 2010-02-12 21:09
    • Final EMA oracle d_labes 2010-02-01 11:53
      • Final EMA oracle Helmut 2010-02-01 12:28
      • Final EMA oracle ElMaestro 2010-02-01 12:50
        • More then two EMA oracles d_labes 2010-02-01 13:30
          • Less of an issue ElMaestro 2010-02-01 15:29
            • Less or More of an issue d_labes 2010-02-01 16:53
              • Less or More of an issue ElMaestro 2010-02-01 17:22
          • Effective with 1 Aug 2010 Helmut 2010-02-02 00:55
          • Bias? ElMaestro 2010-02-04 11:27
            • Bias? Helmut 2010-02-05 02:03
              • Bias? ElMaestro 2010-02-05 09:33
                • Bias? Helmut 2010-02-05 10:21
              • Bias? d_labes 2010-02-05 13:59
              • Bias? ElMaestro 2010-02-05 16:00
                • Bias? Helmut 2010-02-05 19:14
        • Final EMA oracle Helmut 2010-02-01 13:43
          • Final EMA oracle ElMaestro 2010-02-01 14:54
            • Final EMA oracle d_labes 2010-02-01 15:20
              • Teaching Helmut 2010-02-01 16:07
    • Cmin really gone? tmax reappeared? d_labes 2010-02-01 14:02
      • Cmin really gone. tmax reappeared - but how? Helmut 2010-02-01 23:30
    • Interpol or not d_labes 2010-02-01 14:52
      • Interpol! Helmut 2010-02-02 00:02
        • Interpol! ray_be 2010-02-03 18:31
          • WinNonlin/Phoenix extrapolation to t=tau Helmut 2010-02-03 20:26
    • Meta-analysis Helmut 2010-02-07 17:41
    • Final version published Panks.79 2010-03-08 07:22
      • Cmin for MR-formulations? Helmut 2010-03-08 18:16
        • Cmin for MR-formulations? Marcel 2010-04-23 10:09
          • MR-Guideline? Helmut 2010-04-23 12:34
  • Overview of comments published Helmut 2010-02-10 18:33
    • Comments commented d_labes 2010-02-11 08:19
    • Definition of Cmin by EMEA Ravi 2010-03-13 12:05
      • The EMA’s Cmin & WinNonlinHelmut 2010-03-13 12:52