Dossier de médicament expérimental (DME) en RIV

Abstract

The investigational medicinal product dossier (IMPD) is an essential document for setting up clinical trials in the field of radiopharmacy and nuclear medicine. All quality controls carried out on the radiopharmaceutical product under test are centralized in the IMPD. This includes thin layer chromatography (TLC), radio-HPLC, pH testing, sterility testing, filter integrity testing, activity measurement, and possibly volume activity concentration. The stability of the radiopharmaceutical is validated over an extended period to allow flexibility in administration. Interaction tests are carried out to ensure that there is no interaction between the radiopharmaceutical and the vial in which it is dispensed. These steps and elements are crucial to ensure the quality, safety and effectiveness of investigational radiopharmaceuticals before their administration to patients in clinical trials.