Pharmacokinetics/pharmacodynamics and the stages of drug development: Role of modeling and simulation
Journal Title: The AAPS Journal - Year 2005, Vol 7, Issue 3
Abstract
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 the expected variability in PK/PD data generated in preclinical species for projection of the plausible range of clinical dose; clinical trial simulation can be used to forecast the probability of achieving a target response in patients based on information obtained in early phases of development. Framing the right question and capturing the key assumptions are critical components of the “learn-and-confirm” paradigm in the drug development process and are essential to delivering high-value PK/PD M&S results. Selected works of PK/PD modeling and simulation from preclinical to phase III are presented as case examples in this article.
Authors and Affiliations
Jenny Y. Chien, Stuart Friedrich, Michael A. Heathman, Dinesh P. de Alwis, Vikram Sinha
Keywords
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- EP ID EP681888
- DOI 10.1208/aapsj070355
- Views 115
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