Assessing Pharmacokinetics in Liver Disease: Challenges and Future Considerations for Classification of Hepatic Dysfunction and Use of In Silico Methods-Reference-Cited by-同舟云学术

Assessing Pharmacokinetics in Liver Disease: Challenges and Future Considerations for Classification of Hepatic Dysfunction and Use of In Silico Methods

Published:2023-04-20 Issue:7 Volume:63 Page:755-758
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharma

Author:

Sahre Martina D.¹^ORCID,Guinn Daphne¹,Ramamoorthy Anuradha¹,Kim Insook¹,Zhang Xinyuan¹,Mehta Ruby²,Seo Shirley¹,Mehta Mehul¹,Gobburu Joga³^ORCID,Madabushi Rajanikanth¹

Affiliation:

1. Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring Maryland USA

2. Division of Hepatology and Nutrition Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

3. Center for Translational Medicine School of Pharmacy University of Maryland Baltimore Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.2229

Reference15 articles.

1. US Food and Drug Administration.Guidance for Industry ‐ Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design Data Analysis and Impact on Dosing and Labeling.2003.https://www.fda.gov/media/71311/download

2. Surgical considerations in hypertension

3. Comparison of Child-Pugh (CP) criteria and NCI organ dysfunction working group (NCI-ODWG) criteria for hepatic dysfunction (HD): Implications for chemotherapy dosing

4. National Institutes of Health NCI. Protocol Template for Organ Dysfunction Studies. Accessed May 2021.2020.https://ctep.cancer.gov/protocolDevelopment/docs/CTEP_Organ_Dysfunction_Protocol_Template.docx

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