Browsing: regulatory

Journal Articles regulation guidelines

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

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

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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