Scientific Publications by FDA Staff

Clin Pharmacol Ther 2014 Nov;96(5):572-9

Optimizing Dosing of Oncology Drugs.

Minasian L, Rosen O, Auclair D, Rahman A, Pazdur R, Schilsky RL

This purpose of this article is to acknowledge the challenges of optimizing the dosing of oncology drugs and to propose potential approaches to address these challenges in order to optimize effectiveness, minimize toxicity and promote adherence for patients. These approaches could provide better opportunities to understand the sources of variability in drug exposure and clinical outcomes during the development and pre-market evaluation of investigational new drugs.Clinical Pharmacology & Therapeutics (2014); Accepted article preview online 08 AUgust 2014; doi:10.1038/clpt.2014.153.