Multiple dose study for MR product in EU [Regulatives / Guidelines]
When multiple dose study is required To demonstration of Bioequivalence between two MR dosage form for EU.
The European guidance line no. 593 to 595 states as follows:
"A multiple dose study is needed unless a single dose study has been performed with the highest strength which has demonstrated that the mean AUC(0-τ) after the first dose covers more than 90% of mean AUC(0-∞) for both test and reference, and consequently a low extent of accumulation is expected".
Please elaborate or simplify the same for better understanding.