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Advancing Predictio...
Advancing Predictions of Tissue and Intracellular Drug Concentrations Using In Vitro, Imaging and Physiologically Based Pharmacokinetic Modeling Approaches
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- Guo, Yingying (author)
- Eli Lilly & Co, Lilly Corp Ctr, Invest Drug Disposit, Indianapolis, IN 46285 USA
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- Chu, Xiaoyan (author)
- Merck & Co Inc, Depat Pharmacokinet Pharmacodynam & Drug Metab, Kenilworth, NJ USA
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- Parrott, Neil J. (author)
- F Hoffmann La Roche Ltd, Roche Innovat Ctr Basel, Pharmaceut Sci Pharmaceut Res & Early Dev, Basel, Switzerland
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- Brouwer, Kim L. R. (author)
- Univ N Carolina, UNC Eshelman Sch Pharm, Div Pharmacotherapy & Expt Therapeut, Chapel Hill, NC 27515 USA
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- Hsu, Vicky (author)
- US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA
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- Nagar, Swati (author)
- Temple Univ, Sch Pharm, Dept Pharmaceut Sci, Philadelphia, PA 19122 USA
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- Matsson, Pär, 1978- (author)
- Uppsala universitet,Institutionen för farmaci
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- Sharma, Pradeep (author)
- AstraZeneca R&D, IMED Biotech Unit, Safety & ADME Translat Sci Drug Safety & Metab, Cambridge, England
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- Snoeys, Jan (author)
- Janssen R&D, Dept Pharmacokinet Dynam & Metab, Beerse, Belgium
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- Sugiyama, Yuichi (author)
- RIKEN, Res Cluster Innovat, RIKEN Innovat Ctr, Sugiyama Lab, Yokohama, Kanagawa, Japan
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- Tatosian, Daniel (author)
- Merck & Co Inc, Depat Pharmacokinet Pharmacodynam & Drug Metab, Kenilworth, NJ USA
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- Unadkat, Jashvant D. (author)
- Univ Washington, Dept Pharmaceut, Seattle, WA 98195 USA
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- Huang, Shiew-Mei (author)
- US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA
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- Galetin, Aleksandra (author)
- Univ Manchester, Sch Hlth Sci, Ctr Appl Pharmacokinet Res, Manchester, Lancs, England
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(creator_code:org_t)
- 2018-09-12
- 2018
- English.
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In: Clinical Pharmacology and Therapeutics. - : John Wiley & Sons. - 0009-9236 .- 1532-6535. ; 104:5, s. 865-889
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https://doi.org/10.1...
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Abstract
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- This white paper examines recent progress, applications, and challenges in predicting unbound and total tissue and intra/subcellular drug concentrations using in vitro and preclinical models, imaging techniques, and physiologically based pharmacokinetic (PBPK) modeling. Published examples, regulatory submissions, and case studies illustrate the application of different types of data in drug development to support modeling and decision making for compounds with transporter-mediated disposition, and likely disconnects between tissue and systemic drug exposure. The goals of this article are to illustrate current best practices and outline practical strategies for selecting appropriate in vitro and in vivo experimental methods to estimate or predict tissue and plasma concentrations, and to use these data in the application of PBPK modeling for human pharmacokinetic (PK), efficacy, and safety assessment in drug development.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)
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- By the author/editor
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Guo, Yingying
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Chu, Xiaoyan
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Parrott, Neil J.
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Brouwer, Kim L. ...
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Hsu, Vicky
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Nagar, Swati
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Matsson, Pär, 19 ...
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Sharma, Pradeep
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Snoeys, Jan
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Sugiyama, Yuichi
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Tatosian, Daniel
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Unadkat, Jashvan ...
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Huang, Shiew-Mei
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Galetin, Aleksan ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Pharmacology and ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Pharmaceutical S ...
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Clinical Pharmac ...
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Uppsala University