Background: Therapeutic drug monitoring (TDM) and model-informed precision dosing
(MIPD) have greatly benefitted from computational and mathematical advances over the …

Quantitative and systems pharmacology concepts and tools are the foundation of the model‐
informed drug development paradigm at Merck for integrating knowledge, enabling …

The pharmaceutical industry continues to face significant challenges. Very few compounds
that enter development reach the marketplace, and the investment required for each …

US Food and Drug Administration (FDA) has identified innovation in clinical evaluations as a
major scientific priority area. This paper provides case studies and updates to describe the …

Model-informed precision dosing (MIPD) has become synonymous with modern approaches
for individualizing drug therapy, in which the characteristics of each patient are considered …

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 …

Pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation (M&S) are well-
recognized powerful tools that enable effective implementation of the learn-and-confirm …

Patient groups prone to polypharmacy and special subpopulations are susceptible to
suboptimal treatment. Refined dosing in special populations is imperative to improve …

Modelling and simulation (M&S) play an important role in regulatory decision-making that
affects both the public and industry. Technological advances in various fields related to drug …

The development of model‐informed precision dosing (MIPD) tools, especially in the form of
native or web‐based applications to be used at the bedside, has garnered marked attention …