Widened Bound for Scaled Average Bioequivalence

It calculates widened bound for scaled average bioequivalence.

scaledBound(CV = 40, k = 0.76, digits = 4)

Arguments

CV

coefficient of variation in percent

k

0.76 is for EMA and Korea MFDS. US FDA uses 0.893. When CV is 30%, bound becomes (0.8, 1.25). Most regulartory body does not use a more accurate value.

digits

Korea MFDS use 4 digits only, while other regulatory bodies use more decimal values.

Details

CV must be larger than 30%. If CV is larger than 50

Value

widened bound for scaled average bioequivalence

Author

Kyun-Seop Bae <k@acr.kr>

Examples

scaledBound(30)
#> [1] 0.80 1.25
scaledBound(35)
#> [1] 0.7723 1.2948
scaledBound(40)
#> [1] 0.7462 1.3402
scaledBound(45)
#> [1] 0.7215 1.3859
scaledBound(50)
#> [1] 0.6984 1.4319