scaledBound {BE} | R Documentation |
It calculates widened bound for scaled average bioequivalence.
scaledBound(CV = 40, k = 0.76, digits = 4)
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. |
CV must be larger than 30%. If CV is larger than 50
widened bound for scaled average bioequivalence
Kyun-Seop Bae <k@acr.kr>
scaledBound(30)
scaledBound(35)
scaledBound(40)
scaledBound(45)
scaledBound(50)