4.6 Review

Analysis of US Food and Drug Administration Oncology Approvals on the Characterization of Hepatic Impairment Effect and Dosing Recommendations

相关参考文献

注意:仅列出部分参考文献,下载原文获取全部文献信息。
Article Pharmacology & Pharmacy

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

Mohamed Elmeliegy et al.

Summary: This study evaluated the discordance between the Child-Pugh classification and NCIc in patients with hepatic impairment, and the impact on dosing recommendations. The findings showed differences in PK analyses and suggested the need for consistency in classification systems for dosing decisions.

JOURNAL OF CLINICAL PHARMACOLOGY (2021)

Article Pharmacology & Pharmacy

Physiologically-Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective

Tycho Heimbach et al.

Summary: The predictive performance of physiologically-based pharmacokinetics (PBPK) models for pharmacokinetics (PK) in renal impairment (RI) and hepatic impairment (HI) populations was evaluated using clinical data from 29 compounds with 106 organ impairment study arms. The results showed high accuracy in predicting AUC ratios for RI, while inaccuracies were more likely to occur in moderate and severe HI cases. PBPK predictions can help determine the need and timing of organ impairment study.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2021)

Article Pharmacology & Pharmacy

Pharmacokinetics and safety of olaparib in patients with advanced solid tumours and mild or moderate hepatic impairment

Christian Rolfo et al.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2020)

Article Gastroenterology & Hepatology

Burden of liver diseases in the world

Sumeet K. Asrani et al.

JOURNAL OF HEPATOLOGY (2019)

Article Pharmacology & Pharmacy

The Utility of a Population Approach in Drug-Drug Interaction Assessments: A Simulation Evaluation

Diane D. Wang et al.

JOURNAL OF CLINICAL PHARMACOLOGY (2017)

Article Multidisciplinary Sciences

CD38-mediated Ca2+ signaling contributes to glucagon-induced hepatic gluconeogenesis

So-Young Rah et al.

SCIENTIFIC REPORTS (2015)

Review Immunology

Liver fibrosis and repair: immune regulation of wound healing in a solid organ

Antonella Pellicoro et al.

NATURE REVIEWS IMMUNOLOGY (2014)

Article Gastroenterology & Hepatology

Changes in the Prevalence of the Most Common Causes of Chronic Liver Diseases in the United States From 1988 to 2008

Zobair M. Younossi et al.

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY (2011)

Article Gastroenterology & Hepatology

Association between nonalcoholic hepatic steatosis and hepatic cytochrome P-450 3A activity

Dhanashri Kolwankar et al.

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY (2007)

Article Pharmacology & Pharmacy

Liver disease selectively modulates cytochrome P450-mediated metabolism

Reginald F. Frye et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2006)