Bioequivalence and Bioavailability Forum • Sample size for 2waycrossover BE from Parallel BE or 3way BE

Sample size for 2waycrossover BE from Parallel BE or 3way BE [Power / Sample Size]

posted by Dipesh Jayswal – 2007-03-13 11:38 (6247 d 01:05 ago) – Posting: # 573
Views: 6,671

Dear HS,

I have two questions regarding sample size determination for BE study:

1. is it possible to estimate sample size for 2way crossover from parallel BE study????

2. Assume that we have a data for 3way crossover(3 period - 6 sequence) pilot - BE study in which two test products(T1 and T2) were compared with RLD. Now we want to go ahead with either of the test formulation (i.e. either T1 or T2) to be compared with RLD in 2way crossover(2 period - 2 sequence) pivotal study, then how to estimate the correct Sample Size for it???

please suggest me way out or some reading on it????

Thanks in advance.

Dipesh

Complete thread:

Sample size for 2waycrossover BE from Parallel BE or 3way BEDipesh Jayswal 2007-03-13 10:38
- Sample size for 2x2 Xover BE from Parallel BE / 3way BE Helmut 2007-03-13 12:50
  - Sample size for 2x2 Xover BE from Parallel BE / 3way BE Dipesh Jayswal 2007-03-13 13:31
    - Replicate design! Helmut 2007-03-13 13:43
      - Replicate design! Dipesh Jayswal 2007-03-14 08:08