Abstract Pharmacometrics—pharmacokinetics/pharmacodynamics (PK/PD) modeling and
simulation—has been used to inform drug development decisions for more than two …

There is broad recognition, within the pharmaceutical industry that the drug development
process, especially the clinical part of it, needs considerable improvement to cope with rapid …

We propose a framework for considering the role of pharmacokinetic/pharmacodynamic
modeling in drug development and an appraisal of its current and potential impact on that …

Due to frequent clinical trial failures and consequently fewer new drug approvals, the need
for improvement in drug development has, to a certain extent, been met using model-based …

The history of the development of pharmacometrics (PM) is traced from its roots in
pharmacokinetics and pharmacodynamics through population pharmacokinetics to …

The aim of this tutorial is to introduce the concept of physiologically based pharmacokinetic
(PBPK) modeling to individuals in the pharmaceutical industry who may be relatively new to …

The ultimate goal in drug development clinical trials is to investigate the treatment effect and
safety in the intended patient population. The present model for clinical drug development …

In the last 4 years, pharmacometrics (PMX) has advanced to the point that it is now a crucial
part of drug development. Drug delivery systems and molecules with more complex …

We assess the advancement of physiologically based pharmacokinetic (PBPK) modeling
and simulation (M&S) over the last 20 years (start of 2000 to end of 2019) focusing on the …

High development costs and low success rates in bringing new medicines to the market
demand more efficient and effective approaches. Identified by the FDA as a valuable …