Bioequivalence and Bioavailability Forum

normocaloric vs high fat meal [General Statistics]

posted by Helmut – Vienna, Austria, 2010-12-15 14:50 (5661 d 22:25 ago) – Posting: # 6305
Views: 5,728

Dear Dan!

❝ [...] The study was also performed in accordance with this draft guideline.

❝ Only after clinical conduct the revised version of Guideline

❝ CPMP/QWP/EWP/1401/98 Rev. 1 was published. In fact now a high-fat and

❝ high-calorie meal is demanded.

❝ Therefore we performed a second BE study: two-way cross-over single dose

❝ after administration of a high-fat and high-calorie meal in 18 subjects.

Wow, using belt and braces! (German: Gürtel mit Hosenträger) :-D

❝ Would it be possible to evaluate both studies together to show retrospectively

❝ that [...] the demand for a high-fat and high-calorie meal is unnecessary

❝ [...] ? Could I use an inbalanced parallel design approach?

Definitely. You will get estimates of the 'influence of the type of food on BE', both for test and reference.

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

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