Bioequivalence and Bioavailability Forum • Intra subject CV consideration

Intra subject CV consideration [Power / Sample Size]

posted by Sriraj – India, 2010-04-13 11:31 (5915 d 15:45 ago) – Posting: # 5105
Views: 6,899
(edited on 2010-04-13 12:00)

Dear Rasheed,

Thanks for the reply.
According to your mail, we need to conduct a pilot study everytime before conducting the main study, which is not possible and increases cost. If we are performing an exploratory study we dont need to consider one pilot and one main study. Two studies with same design.
According to my knowledge, if we are estimating the sample size for a food-effect study for DrugA, and if have information regarding the CV from another study where DrugA is administered as tablet and capsule formulation, then we can take that CV. But my question is this estimate of CV could not be a realistic one.

Thank you,
SriKanth

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

Complete thread:

Intra subject CV consideration Sriraj 2010-04-12 09:39
- Intra subject CV consideration rasheed 2010-04-13 06:21
  - Intra subject CV considerationSriraj 2010-04-13 09:31
    - Intra subject CV consideration rasheed 2010-04-13 11:19
      - No full quote ! Ohlbe 2010-04-13 12:05
        
        No full quote ! rasheed 2010-04-13 12:25
      - Intra subject CV consideration Sriraj 2010-04-14 09:30
        
        Intra subject CV consideration Dr_Dan 2010-04-14 10:24
        
        Intra subject CV consideration Sriraj 2010-04-14 10:40
        
        Intra subject CV consideration rasheed 2010-04-14 12:35
        Intra subject CV consideration Ohlbe 2010-04-14 15:32
- Intra subject CV consideration statistician 2010-09-27 14:51