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RegisterIs applied biowaiver to lower strengths of suspension form [Dissolution / BCS / IVIVC]
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]
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]
Complete thread:
- Is applied biowaiver to lower strengths of suspension formMauricio Sampaio 2013-07-24 03:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BCS class II problematic Helmut 2013-07-24 14:47
- BCS class II problematic Mauricio Sampaio 2013-07-24 15:29
- BCS class II problematic Helmut 2013-07-24 14:47
Ing. Helmut Schütz