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alagu ☆ India, 2013-08-14 12:27 (4697 d 01:20 ago) Posting: # 11277 Views: 3,821 |
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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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Dr_Dan ★★ Germany, 2013-08-14 13:40 (4697 d 00:07 ago) @ alagu Posting: # 11279 Views: 3,027 |
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Dear alagu Provided that the tablets and the powder for suspension are both immediate release formulations with systemic action then they are regarded as pharmaceutically equivalent if they contain the same amount of the same active substance, since it is generally considered that for immediate release products the concept of essential similarity also applies to different oral forms with the same active substance. In consequence you have to test your powder for suspension against the Canadian and European originator tablet formulation. The US RLD does not matter. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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alagu ☆ India, 2013-08-14 13:55 (4696 d 23:52 ago) @ Dr_Dan Posting: # 11280 Views: 3,252 |
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Thanks for your reply If we want to market the product in Canand & Europe (i.e) Canada Innovator Tablets vs Test powder for suspension then we will market the product in canada if meets BE critria 80 - 125 % its called as Relative bioavaialbility it correct. For Europe all we can do the same its acceptable,because in canada TPD given some critria to met. From your reply i understand Innovator tablets of Canada vs Test product of powder for oral suspension (Relative BA) meets BE critria 80 - 125% its correct. IF Reference produt not available in Europe & Canada but available in US. How do the Bioequivalence study for the product? How to choose Reference for Europe? How to Choose Reference for Canada? What is the critria required for RLD Selection & BE study required? Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! I copypasted your text from another post which I deleted (see here). [Helmut] |
Ing. Helmut Schütz