RLD selection for Europe / Canada [Regulatives / Guidelines]

posted by alagu – India, 2013-08-14 12:27 (4697 d 02:44 ago) – Posting: # 11277
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Selection of Non-Europe & Non - Canadian Reference Product?

The product available in US in the dosage form of Tablets & Powder for suspension.

In Europe Only Tablet dosage form available

In Canada Only Tablet dosage form available

Now how to do Bioequivalence for Powder for supension in Europe & Canada with use of US Reference?

what are requirment for selection of Non - EU & Non canadian reference product criteria?

Finally what are study required for the powder for suspension?

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