Basic concepts in physiologically based pharmacokinetic modeling in drug discovery and development.
Hannah M. Jones,K Rowland‐Yeo +1 more
- Vol. 2, Iss: 8, pp 1-12
TLDR
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 this area and to demonstrate application of this approach in a preclinical and clinical setting.Abstract:
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 this area and to demonstrate application of this approach in a preclinical and clinical setting. The tutorial provides some background on PBPK models and their data requirements, introduces strategies for PBPK modeling in drug development, and includes a discussion on regulatory considerations and potential resource issues.read more
Citations
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Journal ArticleDOI
Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective.
Hannah M. Jones,Yuan Chen,Christopher R. Gibson,Tycho Heimbach,Neil Parrott,Sheila Annie Peters,Jan Snoeys,Vijay V. Upreti,Ming Zheng,Stephen D. Hall +9 more
TL;DR: A cross pharmaceutical industry position on “how PBPK modeling can be applied in industry” is provided focusing on the strategies for application of P BPK at different stages, an associated perspective on the confidence and challenges, as well as guidance on interacting with regulatory agencies and internal best practices.
Journal ArticleDOI
Clinical Pharmacokinetics and Pharmacodynamics of Propofol.
TL;DR: An overview of the PK and PD of propofol is provided in order to refresh readers’ knowledge of its clinical applications, while discussing the main avenues of research where significant recent advances have been made.
Journal ArticleDOI
Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation
Scott Marshall,Rolf Burghaus,V Cosson,Sya Cheung,Marylore Chenel,O DellaPasqua,N Frey,Bengt Hamrén,Lutz Harnisch,F Ivanow,Thomas Kerbusch,Jörg Lippert,Peter A. Milligan,S Rohou,Alexander Staab,JL Steimer,C Tornøe,Sag Visser +17 more
TL;DR: This document was developed to enable greater consistency in the practice, application, and documentation of Model‐Informed Drug Discovery and Development (MID3) across the pharmaceutical industry.
Journal ArticleDOI
Quantitative prediction of human pharmacokinetic responses to drugs via fluidically coupled vascularized organ chips.
Anna Herland,Anna Herland,Anna Herland,Ben M. Maoz,Debarun Das,Mahadevabharath R. Somayaji,Rachelle Prantil-Baun,Richard M. Novak,Michael J. Cronce,Tessa Huffstater,Sauveur S. F. Jeanty,Miles Ingram,Angeliki Chalkiadaki,David B. Chou,Susan Marquez,Aaron Delahanty,Sasan Jalili-Firoozinezhad,Sasan Jalili-Firoozinezhad,Yuka Milton,Alexandra Sontheimer-Phelps,Alexandra Sontheimer-Phelps,Ben Swenor,Oren Levy,Kevin Kit Parker,Kevin Kit Parker,Andrzej Przekwas,Donald E. Ingber,Donald E. Ingber,Donald E. Ingber +28 more
TL;DR: Physiological modelling of first-pass metabolism using data from a robotic instrument that fluidically links relevant organ chips predicts human pharmacokinetic parameters for orally administered nicotine and for intravenously injected cisplatin.
Journal ArticleDOI
Riluzole and edaravone: A tale of two amyotrophic lateral sclerosis drugs.
TL;DR: An overview of the two drugs that have been approved for ALS treatment is provided and an update on the timeline of drug development, how clinical trials were done, the outcome of these trials, primary endpoint, mechanism of actions, dosing information, administration, side effects, and storage procedures are highlighted.
References
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Journal ArticleDOI
Physiological Parameter Values for Physiologically Based Pharmacokinetic Models
Journal ArticleDOI
Utility of in vitro drug metabolism data in predicting in vivo metabolic clearance.
Book
Pharmacokinetic/pharmacodynamic data analysis : concepts and applications
Johan Gabrielsson,Daniel Weiner +1 more
TL;DR: This revised and expanded edition includes a CD with all exercises and WinNonlin model/ command files and raises the stature of PK/PD modeling to its highest level.
Journal ArticleDOI
Dissolution Media Simulating Conditions in the Proximal Human Gastrointestinal Tract: An Update
TL;DR: The updated dissolution media are more physiologically relevant and show better physical stability than their corresponding predecessors and can be used to predict formulation performance and food effects in vivo.
Journal ArticleDOI
Predicting the impact of physiological and biochemical processes on oral drug bioavailability.
TL;DR: The application of a gastrointestinal simulation for the prediction of oral drug absorption and bioavailability will be described and the simulated impact of physiological and biochemical processes on oral drug bioavailability is illustrated.
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