General BE topics [Design Issues]

posted by DavidManteigas – Portugal, 2017-06-12 12:35  – Posting: # 17487
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In my opinion, from my knowledge of the portuguese regulators, there is a lack of members with statistical expertise to properly assess the adequacy of the sample size, or any other question regarding statistical methods, either in Ethics Committees or the regulator.

In my plans for 2018, I will attempt to meet with the portuguese regulator so they can gave me access to their approved studies in bioequivalence in the last years so I can quantify the degree of overpowering of bioequivalence studies when compared to the observed CV and the predicted/guessed/magically obtained predicted CV. My intent is to publish a paper with that information and to sensitize regulators and ethics committees to this issue, which mixes both the sample size calculation and the adequacy of the study design in light of the available information.

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