1. Current Practices and Challenges in Method Validation
- Author
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Simon Lavallée, Adam D. Aulbach, Mehrdad Ameri, Daniela Ennulat, Jennifer Colangelo, Marie-Soleil Piche, Laura Boone, and Florence Poitout
- Subjects
0301 basic medicine ,medicine.medical_specialty ,Toxicology ,Sensitivity and Specificity ,Mass Spectrometry ,Pathology and Forensic Medicine ,03 medical and health sciences ,Toxicity Tests ,Biological validation ,Animals ,Humans ,Medicine ,Medical physics ,Molecular Biology ,Pathology, Clinical ,business.industry ,Reproducibility of Results ,Continuing education ,Cell Biology ,Congresses as Topic ,Reference Standards ,030104 developmental biology ,Research Design ,Biomarker (medicine) ,Biological Assay ,business ,Biomarkers - Abstract
Method validation is a cornerstone on which biomarker development and utilization rest. However, given the abundance of biomarker candidates that are being identified and characterized, validation of these entities for the use in nonclinical studies can be complex. The objective of this continuing education course was to review current practices and challenges encountered during the validation of methods for the analysis of novel biomarkers. Additionally, the importance of biological validation and correlation with pathology end points for biomarker candidates was discussed. This article is a summary of the materials presented at the 36th Annual Symposium of the Society of Toxicologic Pathology for a continuing education course titled “Current Practices and Challenges in Method Validation.” The speakers were subject-matter experts in the validation of quantitative mass spectrometry, multiplex binding assays, biological biomarkers, and immunophenotyping and anatomic and clinical pathology considerations in biomarker qualification.
- Published
- 2018