Browsing: regulatory

Journal Articles regulation guidelines
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Bioanalytical methods must enable the delivery of data that meet sound, scientifically justified, fit-for-purpose criteria. This perspective piece highlights three tiers of method validation – regulatory, scientific and research validations. The criteria for selecting the appropriate application of each of these PK method validation workflows are discussed.

Conference reports EBF Conference report thumbnail
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In this conference report we discuss our highlights from the 10th Open Meeting of the European Bioanalytical Forum – a New Journey begins (Barcelona, Spain; 14–17 November).

Features antibodies-702x336
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In this series we will be discovering what immunogenicity is, why it is important and how is it regulated and standardized.

Regulated bioanalysis
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The purpose of this paper is to describe validation experiments that measure immunocapture efficiency, digestion efficiency, matrix effect and selectivity/specificity that can be used during method optimization and validation to test the resistance of the method to these potential interferences. The designs and benefits of these experiments are discussed in this report using an actual assay case study.

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