Bioequivalence and Bioavailability Forum • Intra subject CV consideration

Intra subject CV consideration [Power / Sample Size]

posted by Sriraj – India, 2010-04-12 11:39 (5918 d 14:15 ago) – Posting: # 5081
Views: 7,914

Dear members,

--> In phase-I trials, mostly we do exploratory studies. Suppose if are doing a food-effect study for new drug say 'drug a', since we are doing the study with food-effect for the first time we will not have any information regarding the intra CV. In such cases how to consider the intra CV for sample size calculation.

--> If we are doing a Drug Drug Interaction study (DDI), period-I NCE, period-II NCE+CoAd. In such cases how to consider intra CV. We may have intra CV information of NCE from different study say NCE food-effect study, and we may have CoAd intra CV with another NCE. In such case which intra CV do we need to consider. CV which is coming from CoAd study or CV from NCE study?

Many thanks in advance,
SriKanth (SriRaj)

Complete thread:

Intra subject CV considerationSriraj 2010-04-12 09:39
- Intra subject CV consideration rasheed 2010-04-13 06:21
  - Intra subject CV consideration Sriraj 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