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ioanam ★ Romania, 2008-04-22 10:50 (6644 d 10:39 ago) Posting: # 1785 Views: 3,828 |
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Dear all, I would like to know if a bioequivalence study between an extended release formulation (considered generic) and the immediate release formulation containing the same active substance (as innovator) is enough for submission in the EU countries. Best regards, Ioana M. |
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Helmut ★★★   Vienna, Austria, 2008-04-22 15:12 (6644 d 06:17 ago) @ ioanam Posting: # 1788 Views: 3,498 |
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Dear Ioana! ❝ […] a bioequivalence study between an extended release formulation (considered generic) and the immediate release formulation containing the same active substance (as innovator) … That’s not a bioequivalence study, because at least the rate of BA is expected to be different. For the design please see the EU guideline (Appendix 1). ❝ … is enough for submission in the EU countries. No. At least one (most likely two) controlled clinical study/studies on safety/efficacy are necessary as well. — 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 |
Ing. Helmut Schütz