Pharmacokinetics/pharmacodynamics and the stages of drug development: Role of modeling and simulation

  title={Pharmacokinetics/pharmacodynamics and the stages of drug development: Role of modeling and simulation},
  author={J. Y. L. Chien and Stuart Friedrich and Michael Heathman and Dinesh P. de Alwis and Vikram Sinha},
  journal={The AAPS Journal},
Pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation (M&S) are well-recognized powerful tools that enable effective implementation of the learn-and-confirm paradigm in drug development. The impact of PK/PD M&S on decision making and drug development risk management is dependent on the question being asked and on the availability and quality of data accessible at a particular stage of drug development. For instance, M&S methodologies can be used to capture uncertainty and use… CONTINUE READING
59 Citations
26 References
Similar Papers


Publications citing this paper.
Showing 1-10 of 59 extracted citations


Publications referenced by this paper.
Showing 1-10 of 26 references

Simulation for Designing Clinical Trials. A Pharmacokinetic-Pharmacodynamic Modeling Perspective

  • HC Kimko, SB Duffull, eds
  • 2003
Highly Influential
6 Excerpts

Model-Based Drug Development: A Critical Path Opportunity

  • DR Stanski
  • Available at:…
  • 2005

of Health and Human Services, FDA

  • U. S. Departmen
  • Challenge and opportunity on the critical path to…
  • 2005

Considerations in the design and development of transport inhibitors as adjuncts to drug therapy

  • A Dantzig, DP de Alwis, M. Burgess
  • Adv Drug Deliv Rev
  • 2003

Evaluation of random sparse sampling designs for a population pharmacokinetic study: Assessment of power and bias using simulations

  • MM Hutmacher, KG Kowalski
  • Kimko HC, Duffull SB, eds. Simulation for…
  • 2003

Similar Papers

Loading similar papers…