Bioequivalence and Bioavailability Forum • sample size in bioequivalence studies

sample size in bioequivalence studies [Power / Sample Size]

posted by balinskyi – Ukraine, 2018-06-03 14:58 (2938 d 22:18 ago) – Posting: # 18844
Views: 18,010

Hello everyone,

I should note, that this formula was published in Ukrainian Pharmacopoeia 1st edition (obsolete since 2016) with reference to Liu and Chow 2008 book. Now, while planning a study, the sponsor has applied the formula (referring to Pharmacopoeia) and consequently argue, that my estimate for the sample size (calculated with PowerTOST) is unnecessarily high. So in my search for an answer I have found this thread. Thank you everyone for the answers!

Complete thread:

sample size in bioequivalence studies daryazyatina 2017-08-03 09:34 [Power / Sample Size]
- sample size in bioequivalence studies BE-proff 2017-08-03 09:55
  - sample size in bioequivalence studies daryazyatina 2017-08-03 10:08
- sample size in bioequivalence studies ElMaestro 2017-08-03 10:17
  - sample size in bioequivalence studies daryazyatina 2017-08-03 10:58
    - sample size in bioequivalence studies DavidManteigas 2017-08-03 12:40
      - sample size in bioequivalence studies daryazyatina 2017-08-03 13:46
      - Don’t use the formula by Chow, Shao, Wang! Helmut 2017-08-03 15:37
        
        Don’t use the formula by Chow, Shao, Wang! daryazyatina 2017-08-03 15:52
        Don’t use the formula by Chow, Shao, Wang! DavidManteigas 2017-08-03 16:12
        
        Don’t use the formula by Chow, Shao, Wang! Helmut 2017-08-03 16:33
        
        Don’t use the Book by Chow, Shao, Wang! d_labes 2017-08-16 16:01
    - compromised power Helmut 2017-08-03 16:04
      - compromised power daryazyatina 2017-08-04 08:15
        
        terminology Helmut 2017-08-04 12:41
        
        terminology daryazyatina 2017-08-16 10:12
        
        terminology Helmut 2017-08-16 18:54
- sample size in bioequivalence studiesbalinskyi 2018-06-03 12:58