Toward Project Optimus for Oncology Precision Medicine: Multi-Dimensional Dose Optimization Enabled by Quantitative Clinical Pharmacology
- PMID: 36264968
- DOI: 10.1002/cpt.2742
Toward Project Optimus for Oncology Precision Medicine: Multi-Dimensional Dose Optimization Enabled by Quantitative Clinical Pharmacology
References
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- US FDA: Project Optimus - reforming the dose optimization and dose selection paradigm in oncology. <https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus...
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- Shah, M., Rahman, A., Theoret, M.R. & Pazdur, R. The drug-dosing conundrum in oncology - when less is more. N. Engl. J. Med. 385, 1445-1447 (2021).
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- Friends of Cancer Research White Paper. Optimizing Dosing in Oncology Drug Development. <https://friendsofcancerresearch.org/wp-content/uploads/Optimizing_Dosing... (2021).
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- Chen, J. et al. Lorlatinib exposure-response analyses for safety and efficacy in a phase I/II trial to support benefit-risk assessment in non-small cell lung cancer. Clin. Pharmacol. Ther. 110, 1273-1281 (2021).
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