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meghalvakil20 ☆ 2016-04-28 01:04 (2910 d 19:16 ago) Posting: # 16253 Views: 6,427 |
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Is there a way we can find out if the generic drug application approved by FDA had submitted BCS waiver for any of the strengths and found to be bioequivalent for example Capecitatine. there are 3 generics approved by US FDA and 2 approval letters posted but how do we know if it was submitted with a BCS waiver and was approved. Edit: Please follow the Forum’s Policy. [Helmut] |
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nobody nothing 2016-04-28 10:31 (2910 d 09:49 ago) @ meghalvakil20 Posting: # 16254 Views: 5,297 |
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Hi there! You mean CAPECITABINE ? Sometimes this here is an option http://www.foiservices.com ...if you want to spend some money  But I don't see anything for generic CAPECITABINE there, yet. You might ask them, if there is an option to get the data, but might cost you some bugs. (OT:...still waiting for the pink to happen. Wait, wait, wait, wait....) — Kindest regards, nobody |
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Mauricio Sampaio ★ Brazil, 2016-05-18 17:58 (2890 d 02:21 ago) @ meghalvakil20 Posting: # 16326 Views: 4,713 |
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Hi! Bad news for you! According Capecitabine Product-Specific Bioequivalence Guidance from EMA, Capecitabine is an unstable compound in acidic medium. Absorption is almost complete. The available data on solubility does not allow its BCS classification. Then, I think that a possibility for biowaiver of capecitabine is impossible according current rules. |
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skycity ☆ China, 2017-01-04 09:19 (2659 d 10:01 ago) @ Mauricio Sampaio Posting: # 16926 Views: 4,041 |
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❝ Hi! ❝ Bad news for you! ❝ According Capecitabine Product-Specific Bioequivalence Guidance from EMA, Capecitabine is an unstable compound in acidic medium. Absorption is almost complete. The available data on solubility does not allow its BCS classification. Then, I think that a possibility for biowaiver of capecitabine is impossible according current rules. Hi! For my mother language isn't English,my English is very poor,and please forgive me  If a drug substance is designated a BCS Class I compound on its properties of being highly solubale,highly permeable and rapidly dissolving drug product,according to BCS waiver industry guidline of FDA and EMA,would I submit the drug product as a BCS waiver and will be passed by FDA? I'm sorry for my bad English,and still wish to get any answer! |
Ing. Helmut Schütz