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taiyab.jameel ☆ India, 2020-03-05 11:02 (1743 d 18:45 ago) Posting: # 21205 Views: 7,350 |
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Hello, We have conducted Fasting BE study for Pantoprazole Sodium delayed release tablets from CRO. As we are filing products in regulated market we have to performed Fed study as per EMEA & FDA guidelines. Now problem is our Test samples are expired but RLD expiry renaming for next 8 months. How can we conduct fed study. What are the challenges we can face after filing. |
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jag009 ★★★ NJ, 2020-03-05 22:57 (1743 d 06:50 ago) @ taiyab.jameel Posting: # 21211 Views: 5,221 |
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Hi ❝ How can we conduct fed study. What are the challenges we can face after filing. Can you make another batch? J |
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taiyab.jameel ☆ India, 2020-03-06 05:15 (1743 d 00:32 ago) @ jag009 Posting: # 21213 Views: 5,219 |
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❝ Can you make another batch? yes we can make another batch, is it acceptable fast and fed study performed on different batch of test product. 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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Helmut ★★★   Vienna, Austria, 2020-03-06 12:21 (1742 d 17:26 ago) @ taiyab.jameel Posting: # 21218 Views: 5,175 |
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Hi Taiyab, ❝ […] is it acceptable fast and fed study performed on different batch of test product. Why not? — 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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taiyab.jameel ☆ India, 2020-03-06 13:26 (1742 d 16:22 ago) @ Helmut Posting: # 21219 Views: 5,173 |
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Thank you everyone for your kind comments. We will do fed study on different batch of test sample for Generic filing. Can we expect any query on authority or specific requirement, we need to met before study initiation. |
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Marcelo Davanco ☆ Campinas, SP, Brazil, 2020-03-06 13:37 (1742 d 16:11 ago) @ taiyab.jameel Posting: # 21220 Views: 5,156 |
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❝ Can we expect any query on authority or specific requirement, we need to met before study initiation. In my opinion, it's important only to send a justification letter (considering expiry date of the Fasting condition batches) following the Fed condition BE reports in order to avoid further authority concerns. 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] — Marcelo Davanço |
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wienui ★ Germany/Oman, 2020-03-07 17:10 (1741 d 12:37 ago) (edited on 2020-03-07 17:56) @ Marcelo Davanco Posting: # 21222 Views: 5,102 |
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Hi All, ❝ In my opinion, it's important only to send a justification letter (considering expiry date of the Fasting condition batches) following the Fed condition BE reports in order to avoid further authority concerns. Why send a justification which is not needed? It is nothing against to use a different batch's for different studies for the the same drug. Best regards, — Cheers, Osama |
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Helmut ★★★ Vienna, Austria, 2020-03-07 23:04 (1741 d 06:43 ago) @ wienui Posting: # 21223 Views: 5,099 |
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Hi Osama, ❝ Why send a justification which is not needed? THX! — 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 |
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Marcelo Davanco ☆ Campinas, SP, Brazil, 2020-03-08 01:32 (1741 d 04:15 ago) @ wienui Posting: # 21224 Views: 5,044 |
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Hi Osama, ❝ Why send a justification which is not needed? ❝ ❝ It is nothing against to use a different batch's for different studies for the the same drug. I agree with you. It was just a suggestion based on our previous experience in Brazil  . Sometimes we need to explain the inexplicable to health authority to avoid delays in the dossier review  BR, Marcelo |
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wienui ★ Germany/Oman, 2020-03-08 11:19 (1740 d 18:29 ago) @ Marcelo Davanco Posting: # 21225 Views: 4,977 |
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Hi Marcelo, ❝ I agree with you. It was just a suggestion based on our previous experience in Brazil The use of a different batch in the fed study as asked above from taiyab.jameel could be better as you can prove batches therpeutic equivalence consistency via in vivo studies. On the contrary, in the case of additional strength biowaiver, it is a must to use the same biobatch for which the therpeutic equivalence was proven before via in vivo BE study. Best regards, — Cheers, Osama |
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ElMaestro ★★★ Denmark, 2020-03-05 23:27 (1743 d 06:20 ago) @ taiyab.jameel Posting: # 21212 Views: 5,221 |
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Hi, ❝ How can we conduct fed study. What are the challenges we can face after filing. Retest, extend the shelf life if within specs, release for CT? — Pass or fail! ElMaestro |
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Dr_Dan ★★ Germany, 2020-03-11 12:39 (1737 d 17:08 ago) @ ElMaestro Posting: # 21239 Views: 4,632 |
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Hi ❝ Retest, extend the shelf life if within specs, release for CT? Right, this is exactly what is also done in phase III trials. But if you use another Test batch you can simply explain this in the clinical overview module 2.5 of the dossier. — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz