Pharmacokinetic Considerations for Organ Dysfunction Clinical Trials in Early Drug Development
A Azaro, ME Demirhan, J Lim, J Rodon - Phase I Oncology Drug …, 2020 - Springer
It is not infrequent that patients with different cancers are affected by bodily organ
dysfunction. Factors such as comorbidities, prior anticancer therapies and tumor-related …
dysfunction. Factors such as comorbidities, prior anticancer therapies and tumor-related …
Organ Dysfunction Trials: Background, Historical Barriers, Progress in Overcoming Barriers, and Suggestions for Future Trials
S Kummar, SP Ivy, PJ Harris - Handbook of Anticancer Pharmacokinetics …, 2014 - Springer
In the past, patients with cancer, who also have hepatic or renal dysfunction, have carried a
triple burden. Not only have they suffered from cancer and organ dysfunction, but until …
triple burden. Not only have they suffered from cancer and organ dysfunction, but until …
[HTML][HTML] Harmonization on renal function assessment is needed during early clinical development of oncology drugs
As with other therapeutic areas, the need to understand the disposition of antineoplastic
drugs in patients who have hepatic and renal dysfunction is paramount during drug …
drugs in patients who have hepatic and renal dysfunction is paramount during drug …
[PDF][PDF] Harmonization of renal function assessment is needed throughout the whole process of anticancer drug development
C Porta, L Cosmai, M Gallieni, MA Perazella - J Clin Oncol, 2016 - researchgate.net
TO THE EDITOR: The article by Beumer et al 1 addressed the effect of renal impairment on
the toxicity of anticancer compounds tested in phase I trials over three decades, and the …
the toxicity of anticancer compounds tested in phase I trials over three decades, and the …
A survey of renal impairment pharmacokinetic studies for new oncology drug approvals in the USA from 2010 to early 2015: a focus on development strategies and …
JJ Xiao, JS Chen, BL Lum, RA Graham - Anti-Cancer Drugs, 2017 - journals.lww.com
Abstract The US Food and Drug Administration (FDA) issued a guidance document in 2010
on pharmacokinetic (PK) studies in renal impairment (RI) on the basis of observations that …
on pharmacokinetic (PK) studies in renal impairment (RI) on the basis of observations that …
Dose recommendations for anticancer drugs in patients with renal or hepatic impairment
SD Krens, G Lassche, FGA Jansman… - The Lancet …, 2019 - thelancet.com
Renal or hepatic impairment is a common comorbidity for patients with cancer either
because of the disease itself, toxicity of previous anticancer treatments, or because of other …
because of the disease itself, toxicity of previous anticancer treatments, or because of other …
Chapter 1: Evaluation of kidney function in patients undergoing anticancer drug therapy, from clinical practice guidelines for the management of kidney injury during …
S Muto, T Matsubara, T Inoue, H Kitamura… - International Journal of …, 2023 - Springer
The prevalence of CKD may be higher in patients with cancer than in those without due to
the addition of cancer-specific risk factors to those already present for CKD. In this review …
the addition of cancer-specific risk factors to those already present for CKD. In this review …
International consensus guideline for anticancer drug dosing in kidney dysfunction (ADDIKD): A standardized approach to assessing kidney function in cancer …
G Sandhu, J Adattini, N O'Neill, E Armstrong Gordon… - 2022 - ascopubs.org
e13518 Background: Anticancer drug dosing recommendations in kidney dysfunction are
often empirical, based on non-standardised creatinine assays calculated via the Cockcroft …
often empirical, based on non-standardised creatinine assays calculated via the Cockcroft …
[PDF][PDF] Do We Have the Right Dose? Dose Adjustments for Organ Dysfunction
MA Rudek - Chemotherapy, 2012 - pdfs.semanticscholar.org
Cancer patients with adequate hepatic or renal function are typically studied in clinical trials.
Since most anticancer agents are cleared via hepatic or renal mechanisms, dose …
Since most anticancer agents are cleared via hepatic or renal mechanisms, dose …
Heterogeneity in methods for estimating renal function in anticancer drug development.
e23002 Background: Accurate assessment of renal function is critical in oncology clinical
trials. Many anti-cancer agents are renally excreted or cleared, and impaired kidney function …
trials. Many anti-cancer agents are renally excreted or cleared, and impaired kidney function …
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