Literature DB >> 25670209

Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective.

H M Jones1, Y Chen, C Gibson, T Heimbach, N Parrott, S A Peters, J Snoeys, V V Upreti, M Zheng, S D Hall.   

Abstract

The application of physiologically based pharmacokinetic (PBPK) modeling has developed rapidly within the pharmaceutical industry and is becoming an integral part of drug discovery and development. In this study, we provide a cross pharmaceutical industry position on "how PBPK modeling can be applied in industry" focusing on the strategies for application of PBPK at different stages, an associated perspective on the confidence and challenges, as well as guidance on interacting with regulatory agencies and internal best practices.
© 2014 American Society for Clinical Pharmacology and Therapeutics.

Mesh:

Year:  2015        PMID: 25670209     DOI: 10.1002/cpt.37

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN: 0009-9236            Impact factor:   6.875


  125 in total

1.  Pharmacists in Australian general practice: an opportunity for expertise in precision medicine.

Authors:  Thomas M Polasek; Andrew Rowland; Michael D Wiese; Michael J Sorich
Journal:  Ther Adv Drug Saf       Date:  2015-10

Review 2.  Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation Approaches: A Systematic Review of Published Models, Applications, and Model Verification.

Authors:  Jennifer E Sager; Jingjing Yu; Isabelle Ragueneau-Majlessi; Nina Isoherranen
Journal:  Drug Metab Dispos       Date:  2015-08-21       Impact factor: 3.922

3.  Physiologically Based Pharmacokinetics of Dexamethasone in Rats.

Authors:  Dawei Song; Le Sun; Debra C DuBois; Richard R Almon; Shengnan Meng; William J Jusko
Journal:  Drug Metab Dispos       Date:  2020-06-29       Impact factor: 3.922

4.  Tissue expression profile of human neonatal Fc receptor (FcRn) in Tg32 transgenic mice.

Authors:  Yao-Yun Fan; Lindsay B Avery; Mengmeng Wang; Denise M O'Hara; Sheldon Leung; Hendrik Neubert
Journal:  MAbs       Date:  2016-04-22       Impact factor: 5.857

Review 5.  Pharmacokinetic and Pharmacodynamic Properties of Drug Delivery Systems.

Authors:  Patrick M Glassman; Vladimir R Muzykantov
Journal:  J Pharmacol Exp Ther       Date:  2019-03-05       Impact factor: 4.030

6.  The pharmaceutical industry needs more clinical pharmacologists.

Authors:  Richard Peck
Journal:  Br J Clin Pharmacol       Date:  2017-08-16       Impact factor: 4.335

Review 7.  State-of-the-Art Review on Physiologically Based Pharmacokinetic Modeling in Pediatric Drug Development.

Authors:  Venkata Yellepeddi; Joseph Rower; Xiaoxi Liu; Shaun Kumar; Jahidur Rashid; Catherine M T Sherwin
Journal:  Clin Pharmacokinet       Date:  2019-01       Impact factor: 6.447

Review 8.  Challenges in working towards an internal threshold of toxicological concern (iTTC) for use in the safety assessment of cosmetics: Discussions from the Cosmetics Europe iTTC Working Group workshop.

Authors:  Corie A Ellison; Karen L Blackburn; Paul L Carmichael; Harvey J Clewell; Mark T D Cronin; Bertrand Desprez; Sylvia E Escher; Steve S Ferguson; Sébastien Grégoire; Nicola J Hewitt; Heli M Hollnagel; Martina Klaric; Atish Patel; Sabrina Salhi; Andreas Schepky; Barbara G Schmitt; John F Wambaugh; Andrew Worth
Journal:  Regul Toxicol Pharmacol       Date:  2019-01-15       Impact factor: 3.271

9.  Physiologically Based Pharmacokinetic Model of the CYP2D6 Probe Atomoxetine: Extrapolation to Special Populations and Drug-Drug Interactions.

Authors:  Weize Huang; Mariko Nakano; Jennifer Sager; Isabelle Ragueneau-Majlessi; Nina Isoherranen
Journal:  Drug Metab Dispos       Date:  2017-08-31       Impact factor: 3.922

Review 10.  Pharmacokinetic studies in pregnancy.

Authors:  Michael J Avram
Journal:  Semin Perinatol       Date:  2020-01-27       Impact factor: 3.300

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