Bioequivalence Flashcards
1
Q
Bioequivalence
A
- same active
- pharmaceutically equivalent
- bioavailabilities after administration in the same molar dose lie within acceptable predefined limits
2
Q
BE study
A
Concentration curve
Ratio of gen:brand of AUC (area under cone-time curve), Cmax (peak plasma conc)
Confidence interval - criteria used to establish BE for ratio should be within acceptance interval of 80.00 - 125.00%
(PK parameters are log-distributed)
CI quantifies uncertainty
‘ range of values within which we can be 90% sure that the true value for the whole population lies’
‘90% certainty that the true difference in the rate and extent of absorption between two brands is no greater than -20% to +25%
