Establishing norms and standards for clinical application of radiolabelled biological proteins, peptides and antibodies. Pharmacodynamic and toxicological recommendations for preclinical studies

In October of 2005 a small group of researchers from different Countries had a meeting at the IAEA headquarters in Vienna, Austria; the aim was to prepare a tentative user-friendly document for personnel involved in preparation of radiopharmaceuticals based on peptides, proteins and antibodies for human use. This document should cover all practical, methodological and ethical concerns relating to radiolabelled products mentioned above and should clarify the complicated road-map that one has to follow in this area. This document does not cover the use of radiolabelled oligonucleotides, cells and other autologous products and does not provide technical protocols on actual methodologies. Herein, we will like to discuss with you some pharmacodynamic and toxicological recommendations for preclinical studies. This guidance only represents my own current thinking in this topic. (Author)