Bioequivalence and Bioavailability Forum

Dear all,

here a gem of statistical knowledge and understanding within regulatory bodies (near non-EU I must confess):
"The MOH commission asked following questions about xxxxxxx:

1. The Cmax value of the point estimator is 82.9 percent
   
2. CV: 44.7
   
3. According to Statistics professor and also literature (Patterson et.al. 2001 Eur. J. Clin. Pharmacol.) the minimum number of subjects should be chosen 56 in Replicate Design, why did you choose 44 subject?

These questions has not been an official letter."
(questions asked after performing the study, emphasis by me)

Seems Douglas Adams has chosen the wrong number as the Answer to the Ultimate Question of Life, the Universe, and Everything .

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Side note: Seems they refer to
Patterson et.al.
"Non-traditional study designs to demonstrate average bioequivalence for highly variable drug.products"
Eur. J. Clin. Pharmacol. 57: 663-670 (2001)