BIOEQUIVALENCY EVALUATION BY COMPARISON OF IN-VITRO DISSOLUTION AND IN-VIVO ABSORPTION USING REFERENCE EQUATIONS

Using in vitro dissolution and in vivo absorption of different generic s or batches for an appropriate drug and dosage form, a reference equa tion of form: k(n)=a+bk(d)+dk(d)(2) can be proposed. In the case of av ailability of standardised in vitro-in vivo data for a specific drug, a Level A a correlation of this type containing experimentally determi ned a, b, d parameters would serve to predict in vivo absorption phase of the drug. The larger number of batches, the stronger will be the p redictive power of these parameters.