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We like to change the formulation of our Ibuprofen sugar coated
tablets. As Ibuprofen show a low solubility in acid media, it does not
comply to the requirements for exemption of a bioequivalence study
according the EU guideline. Has anyone experience with a biowaiver for
ibuprofen?
Ron Liedorp
Regulatory Affairs & Development Manager
Katwijk Farma bv
Archimedesweg 2
2333 CN Leiden
Tel +31 (0)71-5243100
Fax +31 (0)71-5243106
Email rjliedorp.-at-.katwijkfarma.nl
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)