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kiranActimus ☆ India, 2011-05-11 12:36 (4727 d 04:04 ago) Posting: # 7004 Views: 7,836 |
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Dear All Please suggest me whether we can do Fasting and Fed BE Studies of same Molecule with two different batches of RLD? We have conducted fasting pivotal study with one batch of reference product but our client want to go with a different batch of reference product for the fed pivotal study due to unavailabilty of same batch of RLD used for fasting study. Please advise will the studies be acceptable by the US FDA? Thanks in advance. Regards Kiran |
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Helmut ★★★   Vienna, Austria, 2011-05-11 13:35 (4727 d 03:05 ago) @ kiranActimus Posting: # 7007 Views: 7,108 |
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Dear Kiran! ❝ Please suggest me whether we can do Fasting and Fed BE Studies of same Molecule with two different batches of RLD? This is a quite common situation; Yes, you can do that. — 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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kiranActimus ☆ India, 2011-05-11 13:50 (4727 d 02:50 ago) @ Helmut Posting: # 7008 Views: 7,068 |
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Dear Helmut Thanks for the reply. Is there any guidance for the same or it is just a practice? Thanks in advance. Regards Kiran |
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Helmut ★★★ Vienna, Austria, 2011-05-11 13:59 (4727 d 02:41 ago) @ kiranActimus Posting: # 7009 Views: 7,143 |
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Dear Kiran! ❝ Is there any guidance for the same or it is just a practice? No guidance I know of. But you already justified it in your first post: ❝ due to unavailabilty of same batch of RLD used for fasting study. Of course its desirable to have the same batches (in order to perform a between studies comparison); especially for blockbusters it's unlikely that you get the same batch even after a couple of months. If you are lucky and more than one batch is on the market, try to make a selection matching the first batch (content, dissolution). — 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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kiranActimus ☆ India, 2011-05-11 14:12 (4727 d 02:28 ago) @ Helmut Posting: # 7010 Views: 7,081 |
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Dear Helmut Thank you very much for the valuable suggestion. Regards Kiran |
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luvblooms ★★ India, 2011-06-01 11:30 (4706 d 05:10 ago) @ kiranActimus Posting: # 7045 Views: 6,995 |
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Dear Kiran I have a few experience of conducting fast and Fed on different test lot and EMEA/FDA accepting it. Reason: We have put batches 2 out of 3 validation batches for the test and proved bio-equivalence and boasted that these studies proved that our formulations are quite consistent.  Such is life!!!! Luv — ~A happy Soul~ |
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arpit.patel ☆ India, 2017-04-19 08:04 (2557 d 08:36 ago) @ Helmut Posting: # 17250 Views: 5,187 |
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Dear All, I have one concern. Can we use difference batch of RLD in the single BE study.? Is there any guidance for such information.? Thanks in advance. Regards, Arpit |
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ElMaestro ★★★ Denmark, 2017-04-19 11:43 (2557 d 04:57 ago) @ arpit.patel Posting: # 17252 Views: 5,186 |
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Hi arpit.patel, ❝ Can we use difference batch of RLD in the single BE study.? Is there any guidance for such information.? I have good experience with it (EU+US+Brazil). There are sometimes good reasons to do it, and sometimes no way around it. I am not aware of specific guidance. — Pass or fail! ElMaestro |
Ing. Helmut Schütz