Update of Standard Practices for New Method Validation in Forensic Toxicology

: International agreement concerning validation guidelines is important as reporting reliable analytical data is the backbone of forensic bioanalytical research and applications. Guidelines such as those provided by 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) provide a standard for fundamental validation parameters such as selectivity, matrix effects, method limits, calibration, accuracy and stability, as well as other parameters such as carryover, dilution integrity and incurred sample reanalysis. However, it is not always easy for the analyst to ‘translate’ these guidelines into practice. International guidelines remain nonbinding protocols that need to be updated according to the type of application, the analyst’s method requirements and depends on the applied analytical techniques. In this publication, 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, statistical approaches and straightforward acceptance criteria for validation of forensic bioanalytical applications are given.