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Multiple dose study for MR product in EU [Regulatives / Guidelines]

posted by Mahesh M - India, 2014-09-26 11:53  - Posting: # 13591
Views: 2,506

Dear All,

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.

Regards

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