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Jasim Uddin ☆ Bangladesh, 2012-09-04 14:11 (5041 d 20:35 ago) Posting: # 9146 Views: 3,948 |
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Hi! One regulatory authority has asked us to provide Certificate of Analysis of Reference Product/Innovator Product against which we conducted BE Study. Is this a legimate request? If so, how can we set the specification of a product, for example, manufactured by Pfizer? Would appreciate if anyone could help me. Best regards, Jasim |
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Dr_Dan ★★ Germany, 2012-09-04 16:07 (5041 d 18:39 ago) @ Jasim Uddin Posting: # 9147 Views: 3,288 |
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Dear Jasim according to CPMP/QWP/EWP/1401/98 Rev. 1 the selection of the reference product used in a bioequivalence study should be based on assay content and dissolution data which should be determined with the test procedure proposed for routine quality testing of the test product. Once you have these data you can issue a CoA for the reference product. I hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Ohlbe ★★★ France, 2012-09-04 18:13 (5041 d 16:33 ago) @ Dr_Dan Posting: # 9148 Views: 3,340 |
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Dear Jasim, ❝ according to CPMP/QWP/EWP/1401/98 Rev. 1... In addition, according to the next sentence in the same guideline: Unless otherwise justified, the assayed content of the batch used as test product should not differ more than 5% from that of the batch used as reference product determined with the test procedure proposed for routine quality testing of the test product. Regards Ohlbe — Regards Ohlbe |
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Jasim Uddin ☆ Bangladesh, 2012-09-07 17:26 (5038 d 17:20 ago) @ Dr_Dan Posting: # 9159 Views: 3,281 |
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Dear Dan Thanks for the advice. So, we cannot include all parameters in the COA of reference drugs. Because, for a non-compendium product, we cannot have specification of all parameters of a reference products, e.g. uniformity of dosage, average weight etc. What do you suggest? Regards, Jasim Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
Ing. Helmut Schütz