Discordance Between Child‐Pugh and National Cancer Institute Classifications for Hepatic Dysfunction: Implications on Dosing Recommendations for Oncology Compounds-Reference-Cited by-同舟云学术

Discordance Between Child‐Pugh and National Cancer Institute Classifications for Hepatic Dysfunction: Implications on Dosing Recommendations for Oncology Compounds

Published:2020-07-20 Issue:1 Volume:61 Page:105-115
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Elmeliegy Mohamed¹^ORCID,Yang Derek Z.¹²^ORCID,Salama Engie¹²,Parivar Kourosh¹,Wang Diane D.¹

Affiliation:

1. Global Product Development Pfizer Inc. San Diego California USA

2. Skaggs School of Pharmacy & Pharmaceutical Sciences University of California San Diego San Diego California USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1702

Reference29 articles.

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2. Are We Ready to Include Organ-Impaired Patients in Oncology Trials? A Clinical Pharmacology Perspective on Recent Recommendations

3. FDA.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. Accessed June 10 2020.

4. EMA.Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function;2005;https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-pharmacokinetics-medicinal-products-patients-impaired-hepatic-function_en.pdf. Accessed June 10 2020.

5. FDA.Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies;2020;https://www.fda.gov/media/123745/download. Accessed July 13 2020.

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