• Chemistry, Medicine
  • Published in
    Journal of pharmaceutical…
    2012
  • DOI:10.1002/jps.23233

Biowaiver monographs for immediate-release solid oral dosage forms: ketoprofen.

@article{Shohin2012BiowaiverMF,
  title={Biowaiver monographs for immediate-release solid oral dosage forms: ketoprofen.},
  author={Igor E Shohin and Julia I Kulinich and Galina Vladislavovna Ramenskaya and Bertil Abrahamsson and Sabine Kopp and Peter Langguth and James E Polli and Vinod P. Shah and Dirk W Groot and Dirk M. Barends and Jennifer Boehm Dressman},
  journal={Journal of pharmaceutical sciences},
  year={2012},
  volume={101 10},
  pages={
          3593-603
        }
}
Literature and experimental data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing ketoprofen are reviewed. Ketoprofen's solubility and permeability, its therapeutic use and therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability (BA)/dissolution data were taken into consideration. The available data… CONTINUE READING

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