CV of Css,max ≤ CV of Cmax [Power / Sample Size]
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.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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- Multiple dose design Sample size Researcher101 2020-10-14 10:21 [Power / Sample Size]