Modeling and simulation of biopharmaceutical performance.

  title={Modeling and simulation of biopharmaceutical performance.},
  author={Xinyuan Zhang and Robert A. Lionberger},
  journal={Clinical pharmacology and therapeutics},
  volume={95 5},
Biopharmaceutical performance refers to the influence of pharmaceutical formulation variables on in vivo performance. New drug product success depends on formulation design for sufficient bioavailability for clinically desired dosing. Regulatory interest in biopharmaceutical performance includes batch-to-batch consistency, acceptability of postapproval changes, and evaluation of bioequivalence (BE) for generic drug products. This Commentary summarizes biopharmaceutical modeling and simulation… CONTINUE READING