Abstract
Positron Emission Tomography (PET) radiopharmaceuticals development has been experiencing explosive growth due to advances in functional imaging technology and exploration of molecular imaging targets for diagnosis and therapy. There are unique operational and safety requirements of PET radiotracer synthesis when compared to drug synthesis in general. In particular, strict sterility and pyrogenicity requirements, batch-to-batch reproducibility, yield, purity, specific activity, fast synthesis time ( < 2 or 3 T1/2), and radiation protection are defined. The FDA Center of Drug Evaluation and Research (CDER) mandate such requirements for human injection – a distinction between a radiochemical and a radiopharmaceutical. PC-controlled automation of synthetic process is essential for the widespread use of clinical PET providing an essential tool to complying with all aspects of necessary FDA requirements through current good manufacturing practice (cGMP) of human grade radiopharmaceuticals. The FDA regulates automated synthesizers as manufacturing equipment rather than as traditional medical devices.
Keywords: PET, FDA, radiotracers, radiopharmaceuticals, automation, imaging
Call for Papers in Thematic Issues
Intelligent Information Retrieval for Multispectral and Hyperspectral Imaging
Multispectral and hyperspectral imaging is an interdisciplinary research area, widely focuses on spectral, spatial, and temporal data. It offers a plethora of opportunities to efficiently analyze the vast area of the earth's surface. However, there are numerous factors such as dimensionality and size of the hyperspectral data, lesser training samples, ...read more
Machine and Deep Learning in Medical Image Diagnosis
Medical Image Processing regards a set of methodologies that have been developed over recent years with the purpose of improving medical image quality, improving medical data visualization, understanding, and assisting medical diagnosis, and so on. The application of machine and deep learning methods in sensing and imaging can potentially have ...read more
Quantum Machine Learning for Medical Data and Imaging
Quantum computing has promised a significant speedup in certain computationally intensive tasks that are intractable on classical computers. Researchers in quantum machine learning, such as those working in computer vision, image processing, biomedical analysis, and related topics, may play an important role in comprehending and working on complicated medical data, ...read more
16