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 …
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 …
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) …
dedicated to the emerging field of physiologically based pharmacokinetic modeling (PBPK) …
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 …
(PBPK) modeling to individuals in the pharmaceutical industry who may be relatively new to …
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 …
pharmacokinetic (PBPK) models by the pharmaceutical industry and regulatory agencies …
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 …
modeling builds upon its strength to integrate various data to represent a detailed structural …
Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review
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 …
help predict the pharmacokinetics of drugs in humans and evaluate the effects of intrinsic …
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 …
and simulation (M&S) over the last 20 years (start of 2000 to end of 2019) focusing on the …
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 …
developers to evaluate the effect of patient factors on drug exposure. Between June 2008 …
Application of physiologically based pharmacokinetic (PBPK) modeling to support dose selection: report of an FDA public workshop on PBPK
The US Food and Drug Administration (FDA) public workshop, entitled “Application of
Physiologically‐based Pharmacokinetic (PBPK) Modeling to Support Dose Selection …
Physiologically‐based Pharmacokinetic (PBPK) Modeling to Support Dose Selection …