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Amira ☆ Egypt, 2014-12-10 16:30 (3418 d 20:49 ago) Posting: # 14045 Views: 6,471 |
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What if F2 is ok but F1 isn't ok and what could give this result ? |
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Helmut ★★★   Vienna, Austria, 2014-12-10 16:56 (3418 d 20:22 ago) @ Amira Posting: # 14046 Views: 5,251 |
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Hi Amira, ❝ What if F2 is ok but F1 isn't ok and what could give this result ? Welcome to the forum. What if you read the Forum’s Policy you agreed to follow at registration? What’s your purpose of comparing f1? Product development? For BCS-based biowaivers and proportionality waivers (different strengths) you need only f2. — 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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Amira ☆ Egypt, 2015-02-17 20:16 (3349 d 17:02 ago) @ Helmut Posting: # 14446 Views: 4,733 |
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Hi Mr.Helmet, We have regulations in our country to perform a comparative dissolution test before bioequivalence and in these results I face this problem mainly in the actives with low solubility and low release profile without surfactant. What could be done in this case ? ❝ What’s your purpose of comparing f1? Product development? For BCS-based biowaivers and proportionality waivers (different strengths) you need only f2. Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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Helmut ★★★ Vienna, Austria, 2015-02-18 14:23 (3348 d 22:55 ago) @ Amira Posting: # 14457 Views: 4,824 |
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❝ Hi Mr.Helmet, Helmut, not Helmet.  ❝ We have regulations in our country to perform a comparative dissolution test before bioequivalence… Not uncommon. ❝ …and in these results I face this problem mainly in the actives with low solubility and low release profile without surfactant. Add a surfactant. ❝ What could be done in this case ? See above. Note that for BCS classes II/IV in vitro dissolution is rarely predictive of in vivo performance. Even if you find dissimilar dissolution, products might still be BE. If you are in doubt, run a pilot study. Most agencies require in vitro data, but in vivo BE overrules dissolution. I’m not familiar with the Egyptian regulation: Do you mean that you are not allowed to perform a BE study for products lacking dissolution similarity? That would be weird. — 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 |
Ing. Helmut Schütz