The Future of USP Monographs for PET Drugs

As Director of the Duke Medical Center Radiopharmacy, which is permitted by the North Carolina Board of Pharmacy, I am responsible for the procurement, formulation, quality control testing, and dispensing of all radiopharmaceuticals for diagnostic, therapeutic, and research purposes for use in patients in Duke Hospital. Service accomplishments in fiscal year 2011-2012 included providing all radiopharmaceuticals used for routine patient care at Duke Medical Center. In addition, the Radiopharmacy service participated in a wide variety of clinical research protocols undertaken by Duke investigators either by consultation regarding pharmaceutical formulation of research compounds or actually performing these formulations as a specialized service. The major accomplishment over the last several years was to move the Radiopharmacy operation into a new state of the art USP <797> compliant clean room environment. This new lab space is specifically designed to satisfy a wide variety of sterile radiopharmaceutical compounding needs for both routine patient care and clinical research well into the future. My general research interests focus on the development and clinical evaluation of diagnostic and therapeutic radiopharmaceuticals for patient care. Specific research interests focus on the clinical applications of 1.) Carbon C-11, Nitrogen N-13, Oxygen 0-15 and Fluorine F-18 labeled radiopharmaceuticals for Positron Emission Tomography (PET) based molecular imaging and 2.) Radiolabeling antibodies, small molecules and peptides with Gallium Ga-68 for diagnosis and therapeutic radionuclides for treatment of human cancers. Finally, I am interested in the development of radiopharmaceutical care models in nuclear medicine to optimize the patient's health related quality of life, and achieve positive clinical outcomes, within realistic economic expenditures.