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Marcel ★ 2010-04-23 10:10 (5913 d 15:46 ago) Posting: # 5191 Views: 6,129 |
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Good morning Europe! Anyone aware of the state of the BCS as it concerns extended-release formulations? Is there any regulatory movement on this? Can someone suggest any good articles that deals with the BCS and extended-release formulatons? Thank you. |
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Helmut ★★★   Vienna, Austria, 2010-04-23 15:04 (5913 d 10:53 ago) @ Marcel Posting: # 5199 Views: 4,970 |
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Good afternoon Marcel! ❝ Anyone aware of the state of the BCS as it concerns extended-release formulations? Is there any regulatory movement on this? ❝ Can someone suggest any good articles that deals with the BCS and extended-release formulatons? By definition the BCS is only applicable to immediate relase formulations. Or to be more precise: For IR products marketing authorization may be granted based on in vitro studies alone. If it comes to MR-formulations, you will need to perform at least one conventional in vivo study, and may apply for biowaivers for different strenghts - given the conditions in guidelines (proportionality of contents of API, excipients, etc.). — 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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janmacek ☆ Czech Republic, 2010-07-12 15:57 (5833 d 09:59 ago) @ Helmut Posting: # 5607 Views: 4,551 |
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Good afternoon! The WHO Technical Report Series 937 specifies in Annex 7, sections 9.3.3.2 - 9.3.3.4 the requirements for biowaivers in the cases of delayed-release and extended-release tablets and capsules. However, it is not clear to me whether these specifications would be accepted by EMA. Have somebody any experience in this field? Jan |
Ing. Helmut Schütz