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.

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