Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development

clinical pharmacology, FDA reviews, PMR, PMC, molecular entitites, anticancer drug development

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 …

Mar 11^th • 15 mins read