Bioequivalence and Bioavailability Forum

in my protocols… [Power / Sample Size]

posted by Helmut  – Vienna, Austria, 2016-12-29 13:27 (3043 d 09:48 ago) – Posting: # 16903
Views: 10,917

BE-proff

❝ Do you provide calculation of CV upper limit in study protocols?

❝ If yes, how do you explain regulators that you use upper limit instead of CV?

I don’t mention it directly.
I write something like

Based on a conservative estimate of the CV of … obtained from … and assuming a T/R-ratio of …, … subjects are required to obtain at least … power.

—
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Helmut Schütz


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Science Quotes

Complete thread:

• Why do we need pooled CV? BE-proff 2016-08-24 08:48 
  • Maximum CV might be misleading Helmut 2016-08-24 12:07
    • Maximum CV might be misleading BE-proff 2016-08-26 10:41
      • Pooling – example Helmut 2016-08-26 11:34
        • Pooling – example BE-proff 2016-12-28 14:37
          • in my protocols…Helmut 2016-12-29 12:27
  • Why do we need pooled CV? ElMaestro 2016-08-24 13:03
    • Yessir! Common sense! Helmut 2016-08-24 13:53
      • Common sense weighting before pooling mittyri 2016-08-24 15:13
    • Gut feeling is the answer! DavidManteigas 2016-08-25 11:09
      • The reasons not to pool Astea 2016-08-26 20:40
        • The reasons not to pool mittyri 2016-08-28 22:05
        • Know your drug/formulation! Helmut 2016-08-29 11:56