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 …

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 …

Utilization of physiologically based pharmacokinetic modeling in clinical pharmacology and therapeutics: an overview

C Perry, G Davis, TM Conner, T Zhang - Current Pharmacology Reports, 2020 - Springer
The purpose of this review was to assess the advancement of applications for
physiologically based pharmacokinetic (PBPK) modeling in various therapeutic areas. We …

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 …

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 …

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 …

Physiologically based pharmacokinetic (PBPK) modeling and simulation approaches: a systematic review of published models, applications, and model verification

JE Sager, J Yu, I Ragueneau-Majlessi… - Drug Metabolism and …, 2015 - ASPET
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 …

The role of physiologically based pharmacokinetic modeling in regulatory review

SM Huang, M Rowland - Clinical Pharmacology & Therapeutics, 2012 - Wiley Online Library
During regulatory review of clinical pharmacology data in new drug applications and
biologics license applications, questions are routinely asked about how intrinsic factors (eg …

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 …

Physiological‐based pharmacokinetic modeling trends in pharmaceutical drug development over the last 20‐years; in‐depth analysis of applications, organizations …

E El‐Khateeb, S Burkhill, S Murby… - … & Drug Disposition, 2021 - Wiley Online Library
We assess the advancement of physiologically based pharmacokinetic (PBPK) modeling
and simulation (M&S) over the last 20 years (start of 2000 to end of 2019) focusing on the …