Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm

@article{Kesisoglou2015ApplicationOA,
  title={Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm},
  author={Filippos Kesisoglou and Amitava Mitra},
  journal={The AAPS Journal},
  year={2015},
  volume={17},
  pages={1224-1236}
}
Physiologically based absorption models can be an important tool in understanding product performance and hence implementation of Quality by Design (QbD) in drug product development. In this report, we show several case studies to demonstrate the potential application of absorption modeling in rational design of drug product under the QbD paradigm. The examples include application of absorption modeling—(1) prior to first-in-human studies to guide development of a formulation with minimal… CONTINUE READING
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