Bioequivalence and Bioavailability Forum • Sequential designs (history and future)

Sequential designs (history and future) [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2010-03-29 16:19 (5917 d 11:03 ago) – Posting: # 4985
Views: 16,058

Dear bears!

❝ 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?

Well, in Canada and Japan naïve pooling was acceptable for many years (in Canada for almost the last 20 years!). When the sample size turned out to be too small to demonstrate BE, additional subjects could be included – no correction of the alpha-level… Obviously the patient’s risk may be >0.05, but these countries’ inhabitants are proverbial for their endurance (Lumberjacks. Samurais!).
Sequential designs were never part of the official guidelines in the US and the EU. However, the introduction of Potvin’s paper states that sequential design studies were accepted by the FDA in the past. The recent EU-GL allows for a sequential design; the actual method is not stated (but the description matches Potvin’s). Canada in their 2009 draft prefer Gould’s (1995) method.
WHO (2006) allows add-ons; for other countries please search the Guidelines.

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Helmut Schütz

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Complete thread:

Sample Size BA/BE Sriraj 2010-02-26 14:32 [Power / Sample Size]
- 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 CVintra yjlee168 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