Feedback from the European Bioanalysis Forum Workshop: taking tiered approach to the next level.

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-today 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:

[1]  Nathalie Mokrzycki,et al.  Recommendations from the European Bioanalysis Forum on method establishment for tissue homogenates. , 2014, Bioanalysis.

[2]  Vinod P. Shah,et al.  Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays , 2007 .

[3]  N. Weng,et al.  Tiered Approaches to Chromatographic Bioanalytical Method Performance Evaluation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team , 2014, The AAPS Journal.

[4]  P. Timmerman,et al.  Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalysis Forum. , 2010, Bioanalysis.

[5]  Philip Timmerman,et al.  New Frontiers—Accelerator Mass Spectrometry (AMS): Recommendation for Best Practices and Harmonization from Global Bioanalysis Consortium Harmonization Team , 2014, The AAPS Journal.

[6]  Magnus Knutsson,et al.  European Bioanalysis Forum recommendation: scientific validation of quantification by accelerator mass spectrometry. , 2012, Bioanalysis.

[7]  Viswanath Devanarayan,et al.  Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement , 2006, Pharmaceutical Research.

[8]  Philip Timmerman,et al.  Tiered approach revisited: introducing stage-appropriate or assay-appropriate scientific validation. , 2014, Bioanalysis.

[9]  Thomas Pfeifer,et al.  Bioanalysis for plasma protein binding studies in drug discovery and drug development: views and recommendations of the European Bioanalysis Forum. , 2014, Bioanalysis.

[10]  Brian Booth,et al.  When do you need a validated assay? , 2011, Bioanalysis.

[11]  Philip Timmerman.  Tiered approach: from plan into practice. , 2014, Bioanalysis.