Bioequivalence and Bioavailability Forum • Multiple dose design Sample size

Multiple dose design Sample size [Power / Sample Size]

posted by Researcher101 – Egypt, 2020-10-14 12:21 (1646 d 20:47 ago) – Posting: # 21997
Views: 4,069

Dears, I just wanna know if Steadystate Cmax intrasubject variability will be considered in sample size calculations of multiple dose BE? or just Cmax of single dose?

Also is it in the safe side to estimate sample size based on Cmax single dose not multiple dose?

Edit: Category changed; see also this post #1. [Helmut]

Complete thread:

Multiple dose design Sample sizeResearcher101 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 size Researcher101 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