Setting bioequivalence requirements for drug development based on preclinical data: optimizing oral drug delivery systems.

@article{Lipka1999SettingBR,
  title={Setting bioequivalence requirements for drug development based on preclinical data: optimizing oral drug delivery systems.},
  author={Elke Lipka and Gordon L Amidon},
  journal={Journal of controlled release : official journal of the Controlled Release Society},
  year={1999},
  volume={62 1-2},
  pages={41-9}
}
The recently proposed Biopharmaceutics Classification System can be used to classify drugs and set standards for scale-up and post-approval changes as well as standards for in vitro/in vivo correlation for immediate and controlled release products. This classification scheme is based on determining the underlying process that is controlling the drug absorption rate and extent, namely, drug solubility and intestinal membrane permeability. Theoretical analysis and experimental results suggest… CONTINUE READING

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