Organ Impairment—Drug–Drug Interaction Database: A Tool for Evaluating the Impact of Renal or Hepatic Impairment and Pharmacologic Inhibition on the Systemic Exposure of Drugs-Reference-Cited by-同舟云学术

Organ Impairment—Drug–Drug Interaction Database: A Tool for Evaluating the Impact of Renal or Hepatic Impairment and Pharmacologic Inhibition on the Systemic Exposure of Drugs

Published:2015-07-14 Issue:8 Volume:4 Page:489-494
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Yeung CK¹²,Yoshida K³,Kusama M⁴,Zhang H³,Ragueneau‐Majlessi I²,Argon S²,Li L³,Chang P³,Le CD³,Zhao P³,Zhang L³,Sugiyama Y⁴,Huang S‐M³

Affiliation:

1. Department of Pharmacy, School of PharmacyUniversity of WashingtonSeattle Washington USA

2. Drug Interaction Database Program, University of WashingtonSeattle Washington USA

3. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food and Drug AdministrationSilver Spring Maryland USA

4. Laboratory of Pharmaceutical Regulatory Science, Graduate School of Pharmaceutical SciencesUniversity of Tokyo Tokyo Japan

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.55

Reference10 articles.

1. Guidance for Industry: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design Data Analysis and Impact on Dosing and Labeling U.S. Food and Drug Administration. (2003). Accessed January 21 2015.

2. Draft Guidance for Industry Pharmacokinetics in Patients with Impaired Renal Function — Study Design Data Analysis and Impact on Dosing and Labeling U.S. Food and Drug Adminstration. (2010). Accessed January 21 2015.

3. Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function European Medicines Agency. (2014). Accessed January 21 2015.

4. Guideline on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic Function European Medicine Agency. (2005). Accessed January 21 2015.

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