Journal ArticleDOI
Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review.
Ping Zhao,Lei Zhang,Joseph A. Grillo,Qi Liu,Julie Bullock,Y. J. Moon,P. Song,S. S. Brar,Rajnikanth Madabushi,T. C. Wu,Brian Booth,Nam Atiqur Rahman,Kellie S. Reynolds,E Gil Berglund,Lawrence J. Lesko,Huang Sm +15 more
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TLDR
Recent instances of the use of PBPK in decision‐making during regulatory review are reviewed, based on Center for Drug Evaluation and Research reviews of several submissions for investigational new drugs and new drug applications received between July 2008 and June 2010.Abstract:
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 (e.g., organ dysfunction, age, genetics) and extrinsic (e.g., drug-drug interactions) factors, alone or in combinations, on drug exposure. The use of this tool is increasing at all stages of the drug development process. This report reviews recent instances of the use of PBPK in decision-making during regulatory review. The examples are based on Center for Drug Evaluation and Research reviews of several submissions for investigational new drugs (INDs) and new drug applications (NDAs) received between July 2008 and June 2010. The use of PBPK modeling and simulation facilitated the following types of decisions: the need to conduct specific clinical pharmacology studies, specific study designs, and appropriate labeling language. The report also discusses the challenges encountered when PBPK modeling and simulation were used in these cases and recommends approaches to facilitating full utilization of this tool.read more
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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
A critical evaluation of in vitro cell culture models for high-throughput drug screening and toxicity
TL;DR: Common methods of in vitro testing, including dissociated, organotypic, organ/explant, and 3-D cultures, are reviewed here with specific focus on retaining cell and molecular interactions and physiological parameters that determine cell phenotypes and their corresponding responses to bioactive agents.
Journal ArticleDOI
Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation Approaches: A Systematic Review of Published Models, Applications, and Model Verification
TL;DR: A lack of consistency in model development and quality assessment practices is revealed, demonstrating a need for development of best-practice guidelines.
Journal ArticleDOI
Physiologically based pharmacokinetics joined with in vitro-in vivo extrapolation of ADME: a marriage under the arch of systems pharmacology.
TL;DR: PBPK–IVIVE linked models have repeatedly shown their value in guiding decisions when predicting the effects of intrinsic and extrinsic factors on PK of drugs, and a review of the achievements and shortcomings of the models might suggest better strategies in extending the success of PBPK-IVIVE to pharmacodynamics (PD) and drug safety.
Journal ArticleDOI
Organ-On-A-Chip Platforms: A Convergence of Advanced Materials, Cells, and Microscale Technologies.
Samad Ahadian,Robert A. Civitarese,Dawn Bannerman,Mohammad Hossein Mohammadi,Rick Xing Ze Lu,Erika Yan Wang,Locke Davenport-Huyer,Ben Lai,Boyang Zhang,Yimu Zhao,Serena Mandla,Anastasia Korolj,Milica Radisic +12 more
TL;DR: The latest developments in OOC platforms (e.g., liver, skeletal muscle, cardiac, cancer, lung, skin, bone, and brain) are discussed as functional tools in simulating human physiology and metabolism.
References
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Journal ArticleDOI
Physiologically based pharmacokinetic modelling 2: predicting the tissue distribution of acids, very weak bases, neutrals and zwitterions.
Trudy Rodgers,Malcolm Rowland +1 more
TL;DR: Improvement in parameter prediction was largely due to the incorporation of distribution processes related to drug ionisation, an issue that is not addressed in earlier equations.
Journal ArticleDOI
Drug interaction studies: study design, data analysis, and implications for dosing and labeling.
TL;DR: In the past 10 years, clinical pharmacology guidances covering important areas have been issued, including pharmacokinetic data in patients with renal and hepatic impairment, dose‐response studies, and drug‐drug interactions.
Journal ArticleDOI
Physiologically based pharmacokinetic modeling 1: Predicting the tissue distribution of moderate‐to‐strong bases
TL;DR: Overall improvement in prediction should facilitate the further application of WBPBPK modeling, where time, cost and labor requirements associated with experimentally determining Kpu's have, to a large extent, deterred its application.
Journal ArticleDOI
Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor.
TL;DR: The aim of this study was to investigate the safety, pharmacodynamics, and pharmacokinetics of BAY 59–7939, an oral, direct factor Xa inhibitor.
Journal ArticleDOI
Prediction of pharmacokinetics prior to In vivo studies. 1. Mechanism-based prediction of volume of distribution
Patrick Poulin,Frank-Peter Theil +1 more
TL;DR: The present study is the first attempt to develop and validate a mechanistic distribution model for predicting rat and human V(ss) of drugs prior to in vivo studies.
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