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RegisterCV of Css,max ≤ CV of Cmax [Power / Sample Size]
posted by Helmut 
– Vienna, Austria, 2020-10-14 13:27 (2069 d 08:33 ago) – Posting: # 21999
Views: 5,473
Hi Researcher101,
if you have the CV of Cmax from a MD study that’s best, of course.
Yes, since generally (I know only one published exception*) variability in steady state is ≤ the one after a single dose.
if you have the CV of Cmax from a MD study that’s best, of course.
❝ Also is it in the safe side to estimate sample size based on Cmax single dose not multiple dose?
Yes, since generally (I know only one published exception*) variability in steady state is ≤ the one after a single dose.
- Van Hoogdalem EJ, Terpstra IJ, Krauwinkel WJ, Volkers-Kamermans NJ, Baven AL, Verschoor JS. Multiple dose bioequivalence study with josamycin propionate, a drug with highly variable kinetics, in healthy volunteers. Int J Clin Pharmacol Ther. 1996;34(5):202–7. PMID 8738856.
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Complete thread:
- Multiple dose design Sample size Researcher101 2020-10-14 10:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- CV of Css,max ≤ CV of CmaxHelmut 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
Ing. Helmut Schütz