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