Bioequivalence and Bioavailability Forum • Sample size for a pilot study to estimate the CVintra

Sample size for a pilot study to estimate the CVintra [Power / Sample Size]

posted by yjlee168 – Kaohsiung, Taiwan, 2010-03-29 15:27 (5928 d 23:19 ago) – Posting: # 4979
Views: 16,213

Dear Helmut and Elmaestro,

❝ You are right with the sequential designs. If I don't have a lot (!) of previous data, I made them already my new standard.

So, it sounds like that the sequential designs (Method C or D suggested by Potvin D, et al., 2008) have been widely acceptable for regulatory agents (FDA/EMA/Japan/etc.). However, I don't quite remember that there is any regulation mentioned the sequential designs for ABE study. Am I wrong about this? Thanks.

—
All the best,
-- Yung-jin Lee
bear v2.9.6:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here

Complete thread:

Sample Size BA/BE Sriraj 2010-02-26 14:32
- Sample Size BA/BE Helmut 2010-03-01 14:00
  - Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-01 19:25
    - Sample size for a pilot study to estimate the CVintra Helmut 2010-03-01 21:01
      - Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-01 23:47
        
        Sample size for a pilot study to estimate the CVintra Helmut 2010-03-03 19:04
        
        Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-04 22:35
      - 80% confidence ? d_labes 2010-03-19 13:02
        
        75% confidence... Helmut 2010-03-19 14:12
    - Sample size for a pilot study to estimate the CVintra ElMaestro 2010-03-01 22:23
      - Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-02 00:02
      - Sample size for a pilot study to estimate the CVintra Helmut 2010-03-02 02:19
        
        Sample size for a pilot study to estimate the CVintrayjlee168 2010-03-29 13:27
        
        Sample size for a pilot study to estimate the CVintra ElMaestro 2010-03-29 13:39
        
        Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-29 13:47
        
        Sequential designs (history and future) Helmut 2010-03-29 14:19
        
        Sequential designs (history and future) yjlee168 2010-03-29 19:19
        
        Sequential designs (history and future) Helmut 2010-03-29 20:43
        
        Sequential designs (history and future) yjlee168 2010-04-01 18:58
        
        Sequential designs (WinNonlin vs. bear) Helmut 2010-04-02 21:00