Maximum number of steps in sample size search. Set this to a start value for the sample size if a previous run failed. Number of simulations to be performed to obtain the empirical power.
#Fda narrow therapeutic index drugs full#
"2x2x3" is the full replicate with 2 sequences and 3 periods (TRT|RTR). "2x2x4" is the full replicate with 2 sequences and 4 periods (TRTR|RTRT). Heteroscedasticity, the CV of the Test must be given in CV and the one of the Reference in the CV. If given as a vector ( length(CV)=2), i.e., assuming If given as a scalar ( length(CV)=1) the same CV of TestĪnd Reference is assumed (homoscedasticity, CVwT=CVwR). Intra-subject coefficient(s) of variation as ratio (not percent). The value was chosenĬloser to 1 because the potency (contents) settings for NTIDs are tightenedĬonventional lower ABE limit to be applied in the FDA procedure.Ĭonventional upper ABE limit to be applied in the FDA procedure.ĭefaults to 1.25 if not given explicitly. Must be >0 and <1.Īttention! Defaults here to 0.975 if not given explicitly. Print = TRUE, details = TRUE, setseed = TRUE) Replicate design 2x2x4 (TRTR|RTRT) or the 3-period replicate design with sequences TRT|RTR. The FDA’s method for NTIDs based on simulations. This function performs the sample size estimation for the BE decision for Sample size estimation for BE decision via the FDA's method for narrow therapeutic index drugs (NTIDs) R: Sample size estimation for BE decision via the FDA's method.
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