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Biomarker assay validation - PubMed
Source: pubmed.ncbi.nlm.nih.gov
Article summary:
1. This article discusses the importance of biomarker assay validation in drug development and clinical trials.
2. It outlines the regulatory considerations for biomarker assay validation, as well as the need for fit-for-purpose approaches.
3. The article also provides feedback from a European Bioanalysis Forum (EBF) workshop on bringing assay validation and analysis of biomarkers into practice.
Article analysis:
The article is generally reliable and trustworthy, providing an overview of the importance of biomarker assay validation in drug development and clinical trials. The authors provide a comprehensive discussion of the regulatory considerations for biomarker assay validation, as well as the need for fit-for-purpose approaches. Furthermore, they provide feedback from a European Bioanalysis Forum (EBF) workshop on bringing assay validation and analysis of biomarkers into practice.
The article does not appear to be biased or one-sided, presenting both sides equally and exploring counterarguments where appropriate. There is no promotional content or partiality present in the article, and all possible risks are noted throughout. All claims made are supported by evidence, with references provided where necessary.
The only potential issue with this article is that it does not explore all points of consideration in detail; however, this is understandable given its focus on providing an overview rather than a comprehensive discussion of each point raised.