Title:Update of Standard Practices for New Method Validation in Forensic Toxicology
VOLUME: 23 ISSUE: 36
Author(s):Sarah M.R. Wille*, Wim Coucke, Thierry De Baere and Frank T. Peters
Affiliation:Federal Public Service Justice, National Institute of Criminalistics and Criminology, Vilvoordsesteenweg 100, 1120 Brussels, Quality of Medical Laboratories, Scientific Institute of Public Health, J. Wytsmanstraat 14, 1050 Brussels, Federal Public Service Justice, National Institute of Criminalistics and Criminology, Vilvoordsesteenweg 100, 1120 Brussels, Institute of Forensic Medicine, University Hospital Jena, Am Klinikum 1, 07747 Jena
Keywords:Bioanalytical validation, forensic toxicology, international guidelines, experimental set-up, acceptance criteria, quality control.
Abstract:International agreement concerning validation guidelines is important to obtain quality forensic bioanalytical
research and routine applications as it all starts with the reporting of reliable analytical data. Standards for
fundamental validation parameters are provided in guidelines as those from the US Food and Drug Administration
(FDA), the European Medicines Agency (EMA), the German speaking Gesellschaft fur Toxikologie und
Forensische Chemie (GTFCH) and the Scientific Working Group of Forensic Toxicology (SWGTOX). These
validation parameters include selectivity, matrix effects, method limits, calibration, accuracy and stability, as well
as other parameters such as carryover, dilution integrity and incurred sample reanalysis. It is, however, not easy
for laboratories to implement these guidelines into practice as these international guidelines remain nonbinding
protocols, that depend on the applied analytical technique, and that need to be updated according the analyst’s
method requirements and the application type. In this manuscript, a review of the current guidelines and literature
concerning bioanalytical validation parameters in a forensic context is given and discussed. In addition, suggestions
for the experimental set-up, the pros and cons of statistical approaches and adequate acceptance criteria for
the validation of bioanalytical applications are given.
