Application of physiologically based pharmacokinetic (PBPK) modeling to support dose selection: report of an FDA public workshop on PBPK

C Wagner, P Zhao, Y Pan, V Hsu… - CPT …, 2015 - Wiley Online Library
The US Food and Drug Administration (FDA) public workshop, entitled “Application of
Physiologically‐based Pharmacokinetic (PBPK) Modeling to Support Dose Selection …

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 …

Application of PBPK modeling and simulation for regulatory decision making and its impact on US prescribing information: an update on the 2018‐2019 submissions …

X Zhang, Y Yang, M Grimstein, J Fan… - The Journal of …, 2020 - Wiley Online Library
Since 2016, results from physiologically based pharmacokinetic (PBPK) analyses have
been routinely found in the clinical pharmacology section of regulatory applications …

Applications of PBPK/PBBM modeling in generic product development: an industry perspective

K Yuvaneshwari, S Kollipara, T Ahmed… - Journal of Drug Delivery …, 2022 - Elsevier
Physiologically based pharmacokinetic (PBPK) modeling and physiologically based
biopharmaceutics modeling (PBBM) are invaluable tools with wide applications during drug …

[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 …

Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions

P Zhao, M Rowland, SM Huang - Clinical pharmacology & …, 2012 - Wiley Online Library
Physiologically based pharmacokinetic (PBPK) models are increasingly used by drug
developers to evaluate the effect of patient factors on drug exposure. Between June 2008 …

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 …

[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 …

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 …