Bioequivalence and Bioavailability Forum

SR formulations - no MD study? [General Sta­tis­tics]

posted by Helmut  – Vienna, Austria, 2007-01-23 19:32 (6742 d 07:38 ago) – Posting: # 484
Views: 14,461

Dear hirenpharm!

❝ I did not get me right by misfortune.

❝ I meant to say that the AUC(0-last) failing and AUC(0-24)passing.

Hhm, that's bad luck...
One possible reason: your last sampling points are close to LOQ, combined with a relatively long sampling interval (e.g., 16, 24, 36 h). In such a case it happens quite often that in the same subject t(last) will be 24 h for one formulation, and 36 h for the other. Such a difference mainly influences the intra-subject variability--which I would expect to be higher for AUC(last) than for AUC(24). The point estimate should not be influenced as much (differences will mean out).
Unfortunatelly you have to follow your statistical protocol; regulators do not like any kind of 'data dredging' / 'cherry picking'.

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


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Complete thread:

• SR formulations hirenpharm 2007-01-20 10:05 
  • SR formulations - no MD study? Helmut 2007-01-22 19:09
    • SR formulations - no MD study? hirenpharm 2007-01-23 18:13
      • SR formulations - no MD study?Helmut 2007-01-23 18:32
  • SR formulations velupharm 2007-01-23 12:38
    • bioanalytics (LLOQ) Helmut 2007-01-23 19:59
      • bioanalytics (LLOQ) velupharm 2007-01-24 05:36
        • bioanalytics (LLOQ) Helmut 2007-01-24 12:40
          • bioanalytics (LLOQ) joyjac 2007-05-22 02:13
            • bioanalytics (LLOQ) Ohlbe 2007-05-24 23:02