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varsha chungde ☆ India, 2018-10-08 13:34 (2017 d 00:45 ago) Posting: # 19415 Views: 3,639 |
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Hi all, As per guideline we need not to perform any Bioequivalence studies for Injectables. But Enoxaparin sodium being a biologically derived product, is there any need of performing the BA-BE studies. Does the guideline differs for a biologically derived product?  confused: |
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Helmut ★★★   Vienna, Austria, 2018-10-08 13:53 (2017 d 00:26 ago) @ varsha chungde Posting: # 19416 Views: 3,330 |
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Hi Varsha, ❝ As per guideline we need not to perform any Bioequivalence studies for Injectables. It’s not that simple. See e.g., the EMA’s GL page 23. ❝ But Enoxaparin sodium being a biologically derived product, is there any need of performing the BA-BE studies. That’s not the point. See the FDA’s guidance for conditions whether the in vivo PD (!) study can be waived. ❝ Does the guideline differs for a biologically derived product? Differ to what? To get an idea, see the EMA’s guidelines on biosimilars. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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nobody nothing 2018-10-09 12:42 (2016 d 01:37 ago) @ varsha chungde Posting: # 19418 Views: 3,188 |
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❝ As per guideline we need not to perform any Bioequivalence studies for Injectables. That's simply not true at all. There is a (draft) US guidance on BE for enoxaparine. Good starting point. Have fun! — Kindest regards, nobody |
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varsha chungde ☆ India, 2018-10-10 09:09 (2015 d 05:10 ago) @ nobody Posting: # 19423 Views: 3,124 |
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❝ There is a (draft) US guidance on BE for enoxaparine. Good starting point. Have fun! The draft guidance says that we need to prove the sameness between API. 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 #5! [Helmut] |
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ElMaestro ★★★ Denmark, 2018-10-09 13:13 (2016 d 01:07 ago) @ varsha chungde Posting: # 19419 Views: 3,198 |
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Hello varsha, ❝ As per guideline we need not to perform any Bioequivalence studies for Injectables. You mean solutions.  — Pass or fail! ElMaestro |
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varsha chungde ☆ India, 2018-10-10 09:11 (2015 d 05:08 ago) @ ElMaestro Posting: # 19424 Views: 3,140 |
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❝ You mean solutions. Yes i mean injectable aqueous solution. As enoxaparin injection is API in aqueous solution. But enoxaparin being a biotech product, i just needed an clarification. Do we need to prove our AP to be similar or good enough to waive the BE studies. Edit 2018-10-10 07:14: The draft guidance also says to prove the sameness of API. [Varsha] 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 #5! Merged with a later (deleted) post. You can edit your post within 24 hours. [Helmut] |
Ing. Helmut Schütz