ssscv.RdIt calculates sample size for the scaled average bioequivalence test on ratio using coefficient of variation (CV).
ssscv(CV, DesignNo = 1, True.R = 1, Alpha = 0.1, Beta = 0.2, Region = "EU", nMax = 999999)Coefficient of Variation (%)
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 ratio of test/reference
Alpha error level
Beta error level
US or FDA for US FDA, KR or MFDS for Korea MFDS, EU or EMA for other regions or countries
Maximum subject number (sample size) per group
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.
Returns sample size (n per group) for scaled average bioequivalence test with ratio criteria.
ssscv(42.2, DesignNo=4, True.R=0.9) # 14 per group, EU EMA. This applies only for Cmax
#> [1] 14
#> attr(,"Power")
#> [1] 0.8034465
#> attr(,"Bound")
#> [1] 0.7351559 1.3602558
ssscv(42.2, DesignNo=4, True.R=0.9, Region="US") # 9 per group, US FDA
#> [1] 9
#> attr(,"Power")
#> [1] 0.8090626
#> attr(,"Bound")
#> [1] 0.6966198 1.4355032
ssscv(42.2, DesignNo=4, True.R=0.9, Region="KR") # 14 per group, Korea MFDS. Only for Cmax
#> [1] 14
#> attr(,"Power")
#> [1] 0.8032415
#> attr(,"Bound")
#> [1] 0.7352 1.3603