Feedback from the European Bioanalysis Forum Workshop: taking tiered approach to the next level
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This article is available for members, for free, to celebrate Philip Timmerman being awarded the BOSCA – Pillar of the community. In this article, we give feedback on the progress in industry on their efforts to provide practical and tangible solutions for a harmonized implementation of the principles of tiered approach. By describing tiered approach as different levels of scientific validation applied as an alternative to apply established regulatory validation principles [1–4] for studies where the guidance was not the intended scope, we hope to provide an acceptable handle for its adoption for an array of study types in industry....
