qualityassurance ★ 2021-09-26 09:45 (1172 d 05:58 ago) Posting: # 22599 Views: 3,766 |
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Dear Forum members, The question is related to product-specific bioequivalence guidance (EMA) for Ibuprofen draft and Final. The former indicates that the method should be enantioselective and the later indicates the opposite. Of course we should consider the final guidance and not the draft. However, all conditions are fulfilled for (⇒ chiral analytics) and also found some public assessment report where chiral method was used and Pharmacokinetic data were submitted for both enantiomers. Please suggest, whether we should go for chiral or achiral assay? Thank you. |
dshah ★★ India, 2021-09-27 12:22 (1171 d 03:21 ago) @ qualityassurance Posting: # 22600 Views: 3,133 |
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Dear qualityassurance! Kindly follow the final product specific bioequivalence guidance. Previously the sponsor may have followed draft guidance, but on current time it is recommended to follow final guidance. Regards, Dshah |
Helmut ★★★ Vienna, Austria, 2021-09-27 16:52 (1170 d 22:51 ago) @ qualityassurance Posting: # 22601 Views: 3,092 |
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Hi qualityassurance, you selected ☑ E-mail notification if there has been a reply to this message in your post. However, it bounced back from your e-mail provider with the message
Two options:
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Helmut ★★★ Vienna, Austria, 2021-09-27 17:55 (1170 d 21:48 ago) @ qualityassurance Posting: # 22602 Views: 3,025 |
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Hi qualityassurance, I agree with Dshah’s post. From my collection of strange stories: Prior to the 2010 BE-GL a couple of my studies of a certain drug were accepted with an achiral method. Approved in 47 countries. However, since the second condition was unknown, in subsequent studies we used an enantioselective method. It turned out that one enantiomer accounted for >95% of the total AUC.
❝ The question is related to product-specific bioequivalence guidance (EMA) for Ibuprofen… The enantiomeric interconversion of ibuprofen is extremely fast. IMHO, dexibuprofen is a mere marketing joke. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
qualityassurance ★ 2021-10-12 17:15 (1155 d 22:28 ago) @ Helmut Posting: # 22626 Views: 2,795 |
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Dear Helmut and dshah, Thank you for your valuable recommendations. Dear Helmut, Noted the point related to undeliverable email. Regards |