[HTML][HTML] Quality assurance of PBPK modeling platforms and guidance on building, evaluating, verifying and applying PBPK models prudently under the umbrella of …

S Frechen, A Rostami-Hodjegan - Pharmaceutical research, 2022 - Springer
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 …

Applications, challenges, and outlook for PBPK modeling and simulation: a regulatory, industrial and academic perspective

W Lin, Y Chen, JD Unadkat, X Zhang, D Wu… - Pharmaceutical …, 2022 - Springer
Several regulatory guidances on the use of physiologically based pharmacokinetic (PBPK)
analyses and physiologically based biopharmaceutics model (s)(PBBM (s)) have been …

Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective

HM Jones, Y Chen, C Gibson… - Clinical …, 2015 - Wiley Online Library
The application of physiologically based pharmacokinetic (PBPK) modeling has developed
rapidly within the pharmaceutical industry and is becoming an integral part of drug discovery …

Basic concepts in physiologically based pharmacokinetic modeling in drug discovery and development

HM Jones, K Rowland‐Yeo - CPT: pharmacometrics & systems …, 2013 - Wiley Online Library
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 …

[图书][B] Physiologically based pharmacokinetic (PBPK) modeling and simulations: principles, methods, and applications in the pharmaceutical industry

SA Peters - 2021 - books.google.com
Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations The first book
dedicated to the emerging field of physiologically based pharmacokinetic modeling (PBPK) …

Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review

P Zhao, L Zhang, JA Grillo, Q Liu… - Clinical …, 2011 - Wiley Online Library
Physiologically based pharmacokinetic (PBPK) modeling and simulation is a tool that can
help predict the pharmacokinetics of drugs in humans and evaluate the effects of intrinsic …

[HTML][HTML] Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop …

D Jean, K Naik, L Milligan, S Hall… - CPT …, 2021 - ncbi.nlm.nih.gov
Model-informed drug development (MIDD) tools including physiologically based
pharmacokinetic (PBPK) modeling can improve the mechanistic understanding of a drug's …

[HTML][HTML] Recent advances in development and application of physiologically-based pharmacokinetic (PBPK) models: a transition from academic curiosity to regulatory …

M Jamei - Current pharmacology reports, 2016 - Springer
There is a renewed surge of interest in applications of physiologically-based
pharmacokinetic (PBPK) models by the pharmaceutical industry and regulatory agencies …

Physiologically based pharmacokinetics is impacting drug development and regulatory decision making

M Rowland, LJ Lesko… - CPT: pharmacometrics …, 2015 - Wiley Online Library
It is no coincidence that the reports of two meetings, one organized by the US Food and
Drug Administration (FDA), in March 2014, and the other by the UK Medicines and …

[HTML][HTML] Requirements to establishing confidence in physiologically based pharmacokinetic (PBPK) models and overcoming some of the challenges to meeting them

SA Peters, H Dolgos - Clinical pharmacokinetics, 2019 - Springer
When scientifically well-founded, the mechanistic basis of physiologically based
pharmacokinetic (PBPK) models can help reduce the uncertainty and increase confidence in …