The objective of this manuscript is to provide quantitative insights into the tissue distribution
of nanoparticles. Published pharmacokinetics of nanoparticles in plasma, tumor and 13 …

This work provides a perspective on the qualification and verification of physiologically
based pharmacokinetic (PBPK) platforms/models intended for regulatory submission based …

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

Several regulatory guidances on the use of physiologically based pharmacokinetic (PBPK)
analyses and physiologically based biopharmaceutics model (s)(PBBM (s)) have been …

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

Modeling and simulation of drug disposition has emerged as an important tool in drug
development, clinical study design and regulatory review, and the number of physiologically …

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

Modeling and simulation emerges as a fundamental asset of drug development. Mechanistic
modeling builds upon its strength to integrate various data to represent a detailed structural …

In response to a surge of deaths from synthetic opioid overdoses, there have been
increased efforts to distribute naloxone products in community settings. Prior research has …

The use of physiologically based pharmacokinetic (PBPK) modeling to support the drug
product quality attributes, also known as physiologically based biopharmaceutics modeling …