II Workshop on Positron Emitting Radiopharmaceuticals and Molecular Imaging – São Paulo, 2014

GMP EU Guidelines

COMMISSION DIRECTIVE 2003/94/EC (2003) GMP guidelines medicinal
products for human use and investigational medicinal products for human use
GMP Medicinal Products for Human and Veterinary Use Explanatory Notes on the preparation of a Site Master File (v. 4, 2010)download

Medicinal Products for Human and Veterinary Use, Manufacture of Radiopharmaceuticals (v. 4, annex 3, 2008)

Manufacture of investigational medicinal products (v. 4, annex 13, 2003)download

Aulas Prof. Bert Windhorst

Qualification and validation (2001)download
Basics of cyclotron radioisotopes productiondownload
Design and development of radiopharmaceuticalsdownload
Design of a dossier for human applications of new radiopharmaceuticalsdownload
F-18 choline investigational medicinal production dossier (IMPD, 2012)download
Radiochemistry of carbon‐11 , nitrogen‐13 and oxygen‐15download
Radiochemistry of fluorine‐18 and iodine‐123/124download
Radiopharmaceutical and radioisotopes regulatory issues in Europedownload
Nuclear Medicine & PET Research VUMC (2006)download

S. Vallabhajosula, Molecular Imaging: Radiopharmaceuticals for PET and SPECT, Springer-Verlag Berlin Heidelberg 2009

Capítulo 5, Production of Radionuclidesdownload
Capítulo 10, Chemistry of Radiohalogens (F, Br. and I)download
Capítulo 11, Chemistry of Organic Radionuclides (C, N, and O)download