BE (version 0.2.4)

ssscv: 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)

Value

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

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

Author

Kyun-Seop Bae <[e-mail]>

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.

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