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mayur661 ☆ India, 2010-06-02 16:57 (5864 d 04:11 ago) Posting: # 5411 Views: 4,692 |
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Dr_Dan ★★ Germany, 2010-06-02 17:11 (5864 d 03:56 ago) @ mayur661 Posting: # 5414 Views: 3,965 |
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Hi just some questions: Dose proportional pharmacokinetics? Dose proportional formulations and biowaiver criteria applicable? If both criteria apply your first formulation will have half the bioavailability of the second formulation, i.e. absolut bioinäquivalent but relative bioequivalent. What is the reason for two different doses (strengths)? Regards Dan — Kind regards and have a nice day Dr_Dan |
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mayur661 ☆ India, 2010-06-03 16:28 (5863 d 04:39 ago) @ Dr_Dan Posting: # 5426 Views: 3,905 |
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Helmut ★★★   Vienna, Austria, 2010-06-03 16:38 (5863 d 04:30 ago) @ mayur661 Posting: # 5427 Views: 4,165 |
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See this post. If you are not willing to comply with the Forum's Policy and continue posting in a rude tone, your account will be blocked. — 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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Dr_Dan ★★ Germany, 2010-06-03 17:06 (5863 d 04:02 ago) @ mayur661 Posting: # 5429 Views: 3,871 |
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Dear Mayur661 Honestly, if you know, that there is such a significant food effect on only the reference formulation that you need twice the dose compared to test, how can you think to reach bioequivalence in the fed state? You have a different formulation with a different PK characteristic and different food effect. No chance, you have to reformulate! Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz