Two stage design in a 4 way crossover fasting-fed BE study [Design Issues]

posted by Tina – India, 2014-05-16 12:35 (4422 d 06:48 ago) – Posting: # 12954
Views: 7,216

Dear Helmut,

Is it possible to have a two-stage design in a 4-way crossover study (involving fasting and fed of both R and T) if variability observed between the two conditions differ pointing to 2 different sample sizes for fasting and fed.

Suppose fasting reuires 60 subjects and fed requires 100 subjects, do we have to dose 100 subjects intoto or to separate the sample sizes?

Kind regards,
Tina

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