Physiologically based pharmacokinetic (PBPK) modeling and simulation can be used to
predict the pharmacokinetic behavior of drugs in humans using preclinical data. It can also …

Although oral drug delivery is the preferred administration route and has been used for
centuries, modern drug discovery and development pipelines challenge conventional …

The aim of this tutorial is to introduce the fundamental concepts of physiologically based
pharmacokinetic/pharmacodynamic (PBPK/PD) modeling with a special focus on their …

The application of physiologically based pharmacokinetic (PBPK) modeling has developed
rapidly within the pharmaceutical industry and is becoming an integral part of drug discovery …

There is a renewed surge of interest in applications of physiologically-based
pharmacokinetic (PBPK) models by the pharmaceutical industry and regulatory agencies …

Classic pharmacokinetics (PK) rarely takes into account the full knowledge of physiology
and biology of the human body. However, physiologically based PK (PBPK) is built mainly …

The goal of pharmacovigilance is to detect, monitor, characterize and prevent adverse drug
events (ADEs) with pharmaceutical products. This article is a comprehensive structured …

Developmental changes in children can affect the disposition and clinical effects of a drug,
indicating that scaling an adult dose simply down per linear weight can potentially lead to …

The fields of toxicology and chemical risk assessment seek to reduce, and eventually
replace, the use of animals for the prediction of toxicity in humans. In this context …

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 …