Bioequivalence and Bioavailability Forum • Multiple dose design Sample size

Multiple dose design Sample size [Power / Sample Size]

posted by Researcher101 – Egypt, 2020-10-14 15:37 (1431 d 06:47 ago) – Posting: # 22000
Views: 2,610
(edited by on 2020-10-19 10:41)

Also if Cmax ss within variability is around 20 % and Cmin ss within variability is around 41 % on which one should I depend

Dears, I am asking about the factor we determine the sample size in multiple dose studies? Should I estimate sample size based on intra subject variability of Cmin or Cmax or C tau?

Can I pool the CVs to estimate sample size?

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]

Edit: Post merged with a new (deleted) post of 2020-10-19. Relax; see also this post #9. [Helmut]

Complete thread:

Multiple dose design Sample size Researcher101 2020-10-14 10:21 [Power / Sample Size]
- CV of Css,max ≤ CV of Cmax Helmut 2020-10-14 11:27
- Multiple dose design Sample sizeResearcher101 2020-10-14 13:37
  - Sample size based on worst case Helmut 2020-10-19 16:17
  - Multiple dose design Sample size dshah 2020-10-20 06:43