The Regulatory Process: The Institute for Clinical PET’s Experience
Sponsor a Drug Master File (DMF) for 2-[18F]FDG
Examine Good Manufacturing Practices (GMP’s) for routine, clinical production of 2-[18F]FDG
Coordinate development of a hospital-sponsored New Drug Application (NDA) for 2-[18F]FDG.
KeywordsGood Manufacture Practice Radionuclidic Purity Production Record Clinical Production Aseptic Processing
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