Article
Peter N Morcos, Junyi Li, Iraj Hosseini, Chi‐Chung Li
Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development
Summary
The article discusses optimizing oncology drug development, focusing on the impact of pharmacokinetic factors like food effects and drug interactions. It recommends early evaluation of these factors to enhance dosing accuracy and patient compliance. Advanced modeling and simulation are suggested to improve dose selection and expedite drug approval with robust prescribing guidance.
We conducted a comprehensive analysis of clinical pharmacology evaluations in initial submissions of 56 oncology new molecular entities approved by the US Food and Drug Administration between January 2011 and April 2017. Results from studies evaluating food effect, QTc prolongation, drug-drug interactions, renal and hepatic impairment effects, and dose optimization, as well as postmarketing requirements/commitments, were reviewed. This reverse translational research highlights the importance of clinical pharmacology and pharmacometrics in benefit-risk characterization, regulatory review, and labeling of anticancer therapeutics.
clinical pharmacology, FDA reviews, PMR, PMC, molecular entitites, anticancer drug development
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