Technical validation of radioluminography systems

Citation
H. Kolbe et G. Dietzel, Technical validation of radioluminography systems, REGUL TOX P, 31(2), 2000, pp. S5-S14
Citations number
5
Categorie Soggetti
Pharmacology & Toxicology
Journal title
REGULATORY TOXICOLOGY AND PHARMACOLOGY
ISSN journal
02732300 → ACNP
Volume
31
Issue
2
Year of publication
2000
Part
2
Supplement
S
Pages
S5 - S14
Database
ISI
SICI code
0273-2300(200004)31:2<S5:TVORS>2.0.ZU;2-W
Abstract
More and more laboratories are forced to document evidently that experiment al results were achieved compliant with the regulatory of Good Laboratory P ratice (GLP). Thus, also for the imaging plate technique, which is widely u sed in whole-body autoradiography, it is necessary to provide procedures fo r formal validation and continuous quality control. Therefore, several Euro pean pharmaceutical companies agreed to carry out a project on this subject . This part considers the technical validation. Methods to prove uniform se nsitivity and resolution of the technique were developed and are suggested as standard operation procedures and demonstrated, as well, by examples usi ng the isotope C-14. The high linearity of the detection method is shown by performing a calibration of the image data to the applied radioactivity. ( C) 2000 Academic Press.