Evaluation of Exposure Change of Nonrenally Eliminated Drugs in Patients With Chronic Kidney Disease Using Physiologically Based Pharmacokinetic Modeling and Simulation-Reference-Cited by-同舟云学术

Evaluation of Exposure Change of Nonrenally Eliminated Drugs in Patients With Chronic Kidney Disease Using Physiologically Based Pharmacokinetic Modeling and Simulation

Published:2012-01 Issue:S1 Volume:52 Page:
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Zhao Ping¹,Vieira Manuela de L. T.¹²,Grillo Joseph A.¹,Song Pengfei¹,Wu Ta‐Chen¹,Zheng Jenny H.¹,Arya Vikram¹,Berglund Eva Gil³,Atkinson Arthur J.⁴,Sugiyama Yuichi⁵,Pang K. Sandy⁶,Reynolds Kellie S.¹,Abernethy Darrell R.¹,Zhang Lei¹,Lesko Lawrence J.¹,Huang Shiew‐Mei¹

Affiliation:

1. Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, MD, USA

2. Department of Pharmaceutics, University of Florida, Gainesville, FL, USA

3. Medical Products Agency, Uppsala, Sweden

4. Northwestern University, Chicago, IL, USA

5. Department of Molecular Pharmacology, University of Tokyo, Japan

6. Leslie Dan Faculty of Pharmacy, University of Toronto, Canada

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1177/0091270011415528

Reference51 articles.

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4. Draft Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function ‐ Study Design Data Analysis and Impact on Dosing and Labeling;2010.http:www.fda.govdownloadsDrugsGuidanceComplianceRegulatoryInformationGuidancesUCM204959.pdf. Accessed October 4 2011.

5. Drug Development Perspective on Pharmacokinetic Studies of New Drugs in Patients With Renal Impairment

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