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

@article{Shohin2012BiowaiverMF,
  title={Biowaiver monographs for immediate-release solid oral dosage forms: ketoprofen.},
  author={I. E. Shohin and Julia I Kulinich and Galina 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 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… 

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TLDR
A biowaiver for immediate release (IR) ibuprofen solid oral drug products is scientifically justified, provided that the test product contains only those excipients reported in this paper in their usual amounts.
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TLDR
If a drug exhibits dose-linear pharmacokinetics and a sufficiently fast dissolution profile, it can be concluded that this drug appears to pose no problem with respect to absorption, and biowaivers can be granted on the basis of standard pharmacokinetic data.
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Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms
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TLDR
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TLDR
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TLDR
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TLDR
The relative bioavailability of ketoprofen from a liquid formulation as compared to a tablet formulation as reference after single oral dose administration was investigated in 16 healthy male subjects and remarkable differences in the shape of concentration-time courses between the two formulations were found.
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TLDR
The highly soluble potassium salt of diclofenac was rapidly absorbed, especially in its sachet formulation, and thus appears to be an invaluable analgesic agent that is particularly useful for quick pain relief.
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