What is now current good manufacturing practice for PET drugs?
The new CGMP for PET pharmaceuticals will significantly affect the nuclear medicine community. The documentation, and in some cases the processes for the production, quality assurance, and distribution of PET pharmaceuticals will have recommended changes. The average yearly cost of the implementation of the final rule is estimated to be about 2,450,000 dollars, not counting start-up costs.
Harolds
Jay
J
Department of Radiological Sciences, University of Oklahoma, Health Sciences Center, Oklahoma City, OK 73126-0901, USA. Jay-Harolds@ouhsc.edu
D004335:Drug and Narcotic Control; D049268:Positron-Emission Tomography / Q000592:standards*; D017410:Practice Guidelines as Topic; D011786:Quality Control; D019275:Radiopharmaceuticals / Q000191:economics / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
D019275:Radiopharmaceuticals