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

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