Systematic and quantitative assessment of the effect of chronic kidney disease on CYP2D6 and CYP3A4/5-Reference-Cited by-同舟云学术

Systematic and quantitative assessment of the effect of chronic kidney disease on CYP2D6 and CYP3A4/5

Published:2016-03-07 Issue:1 Volume:100 Page:75-87
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Yoshida K¹,Sun B¹²,Zhang L¹,Zhao P¹,Abernethy DR¹,Nolin TD³,Rostami‐Hodjegan A⁴⁵,Zineh I¹,Huang S‐M¹

Affiliation:

1. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and ResearchU.S. Food and Drug AdministrationSilver Spring Maryland USA

2. Department of Pharmacy, Shanghai General Hospital, School of MedicineShanghai Jiao Tong UniversityShanghai P. R. China

3. Center for Clinical Pharmaceutical Sciences, Department of Pharmacy and Therapeutics, and Department of Medicine Renal‐Electrolyte DivisionUniversity of Pittsburgh Schools of Pharmacy and MedicinePittsburgh Pennsylvania USA

4. Centre for Applied Pharmaceutical Research, Manchester Pharmacy SchoolUniversity of ManchesterManchester UK

5. Simcyp (a Certara Company)Sheffield UK

Funder

US Food and Drug Administration's (FDA) Medical Countermeasures initiative

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.337

Reference50 articles.

1. Is This the Drug or Dose for You?: Impact and Consideration of Ethnic Factors in Global Drug Development, Regulatory Review, and Clinical Practice

2. Public Health Consequences of Chronic Kidney Disease

3. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER).Draft Guidance / Guidance for Industry. Pharmacokinetics in Patients with Impaired Renal Function — Study Design Data Analysis and Impact on Dosing and Labeling. (2010). Accessed 26 March 2015.

4. European Medicines Agency.Draft guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function. (2014). Accessed 26 March 2015.

5. Emerging Evidence of the Impact of Kidney Disease on Drug Metabolism and Transport

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