Bioanalysis Zone

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. The principles of tiered approach became gradually known in regulated bioanalysis about a decade ago [5,6], received positive comments by Health Authority (HA) representatives [7], and were further propagated in regulated bioanalysis with the support of industry consortia [8,9]. Going forward, the bioanalytical community identified more areas in scope of application for tiered approach in a recently published special focus issue of Bioanalysis [10]. The practice of adopting less rigorous (or exhaustive) validation requirements in earlier stages of development, as highlighted in recent (draft) guidance [11] and confirmed during discussions at the recent Crystal City V meeting (Baltimore, MD, USA, 3–5 December 2013) stimulated the European Bioanalysis Forum (EBF) to organize a special workshop on Tiered Approach in June 2014 (Brussels, Belgium) to seek further alignment and provide practical solutions to bring tiered approach to the next level; in other words, in day-to-day practice. The aim of the workshop, which started from a simple paradigm that a validated assay does not necessarily equate to valid data, was fourfold

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