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Mauricio Sampaio ★ Brazil, 2013-07-24 05:45 (4711 d 18:58 ago) Posting: # 11045 Views: 5,741 |
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Is applied biowaiver to lower strengths of suspension formulation? e.g: the bioequivalence result of ibuprofen 100 mg/ ml suspension could be applied to biowaiver of 50 mg/ ml or 20 mg/ ml? I am assuming that all strengths are proportional in their composition and pharmacokinetics are linear between 20 mg/ml and 100 mg/ml. Thank you in advance for any reply. Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2013-07-24 16:47 (4711 d 07:56 ago) @ Mauricio Sampaio Posting: # 11048 Views: 4,815 |
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Hi Mauricio! ❝ Is applied biowaiver to lower strengths of suspension formulation? Why not? Of course if the usual conditions of a BCS-based biowaiver are fulfilled. ❝ e.g: the bioequivalence result of ibuprofen 100 mg/ ml suspension … As a weak acid ibuprofen belongs to BCS class II. Although FIP recommended a biowaiver already in one of their first monographs, ANVISA is very restrictive in this respect. Consider asking Rodrigo Cristofoletti. — 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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Mauricio Sampaio ★ Brazil, 2013-07-24 17:29 (4711 d 07:13 ago) @ Helmut Posting: # 11049 Views: 4,787 |
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Hi Helmut! I like when you give a reply! You understand exactly my problem! Recently I received a return saying that biowaiver to Ibuprofen is not applied! I know that FDA has the same recommendation to Ibuprofen 100 mg/ ml (20 mg/ ml), but according Orange Book there is just this strength in the market. Then, I think that is obvious that waiver is not applied! Thank you again for you support! |
Ing. Helmut Schütz