Bioanalysis, a MEDLINE indexed journal for bioanalysts, has released its Special Focus Issue on 'Biomarker Assay Validation (BAV)'.
This Special Focus Issue will offer readers of the journal an insight into the various issues that exist surrounding the BAV, how these issues have evolved over the years, as well as the recent regulatory activities around these.
This issue was guest edited by Steven Piccoli (Neoteric) and Fabio Garofolo (Angelini Pharma).
In this issue, parallelism assessments in LBA biomarker assay development and validation, clinical biomarker validation, the evolution of fit-for-purpose biomarker validations as well as many other important topics are discussed by experts and key opinion leaders in the biomarker field.
Another highlight of this issue is the progress update for the C-Path White Paper on the joint FDA &C-Path Initiative collaboration on analytical validation of biomarker assays used in the FDA biomarker qualification process.
The full issue is available online here at http://www.future-science.com/toc/bio/10/12.
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