Pharmacokinetics/pharmacodynamics and the stages of drug development: Role of modeling and simulation
Citations Over TimeTop 10% of 2005 papers
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.
Related Papers
- → The increasing doses of methotrexate pharmacokinetics after intravenous administration in rats - model selection(2019)3 cited
- → Pharmacokinetics of 2',3'-dideoxyinosine in monkeys(1991)20 cited
- Pharmacokinetics of monoclonal antibody HAb 18 and its F(ab^)_(2) and fab fragments in mice(1996)
- Pharmacokinetics and tissue distribution of Chuanhuning emuslion in rats(2014)