ssscv: Sample Size for Scaled Average BE using coefficient of...

In BE: Bioequivalence Study Data Analysis

Sample Size for Scaled Average BE using coefficient of variation (CV)

Description

It calculates sample size for the scaled average bioequivalence test on ratio using coefficient of variation (CV).

Usage

ssscv(CV, DesignNo = 1, True.R = 1, Alpha = 0.1, Beta = 0.2, Region = "EU", nMax = 999999)

Arguments

CV	Coefficient of Variation (%)
DesignNo	Crossover design number. Design Number (treatment x sequence x period) 1 2x2x2 : RT TR 2 2x4x2 (Balaam Design) : TT RR RT TR 3 2x2x3 (Two-sequence Dual Design): TRR RTT 4 2x2x4 : TRRT RTTR 5 2x4x4 : TTRR RRTT TRRT RTTR 6 3x6x3 (William Design for 3 treatments) + carry-over effect : RBA ARB BAR ABR BRA RAB 7 3x6x3 (William Design for 3 treatments) - carry-over effect : RBA ARB BAR ABR BRA RAB 8 4x4x4 (William Design for 4 treatments) + carry-over effect : RCAB ARBC BACR CBRA 9 4x4x4 (William Design for 4 treatments) - carry-over effect : RCAB ARBC BACR CBRA
True.R	True ratio of test/reference
Alpha	Alpha error level
Beta	Beta error level
Region	US or FDA for US FDA, KR or MFDS for Korea MFDS, EU or EMA for other regions or countries
nMax	Maximum subject number (sample size) per group

Details

It calculates sample size (n per group) with CV, Alpha, and Beta for scaled average bioequivalence test. US FDA uses this widened bound for both AUClast and Cmax, while EU EMA and Korea MFDA use this for Cmax only.

Value

Returns sample size (n per group) for scaled average bioequivalence test with ratio criteria.

Author(s)

Kyun-Seop Bae <[e-mail]>

Examples

ssscv(42.2, DesignNo=4, True.R=0.9) # 14 per group, EU EMA. This applies only for Cmax
ssscv(42.2, DesignNo=4, True.R=0.9, Region="US") # 9 per group, US FDA
ssscv(42.2, DesignNo=4, True.R=0.9, Region="KR") # 14 per group, Korea MFDS. Only for Cmax

BE documentation built on Jan. 7, 2023, 1:11 a.m.