title: Technical validation of radioluminography systems.
abstract: More and more laboratories are forced to document evidently that experimental results were achieved compliant with the regulatory of Good Laboratory Pratice (GLP). Thus, also for the imaging plate technique, which is widely used in whole-body autoradiography, it is necessary to provide procedures for formal validation and continuous quality control. Therefore, several European pharmaceutical companies agreed to carry out a project on this subject. This part considers the technical validation. Methods to prove uniform sensitivity and resolution of the technique were developed and are suggested as standard operation procedures and demonstrated, as well, by examples using the isotope (14)C. The high linearity of the detection method is shown by performing a calibration of the image data to the applied radioactivity.
authors.affiliation: raytest Isotopenmessgeräte GmbH, Benzstrasse 4, Straubenhardt, D-75334, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Kolbe
authors.forename: G
authors.initials: G
authors.lastname: Dietzel
mesh_terms: D001345:Autoradiography / Q000379:methods / Q000592:standards; D005060:Europe; D006801:Humans; D007391:International Cooperation; D007753:Laboratories / Q000592:standards*; D011786:Quality Control; D011874:Radiometry / Q000379:methods / Q000592:standards*; D015203:Reproducibility of Results; D014915:Whole-Body Counting / Q000592:standards*