Module 9 2024

03/09/2024

Acronyms

• Ab: antibody • ADA: anti-drug antibody • CLBA: competitive ligand binding assay • ECL: electrochemiluminescence • ELISA: enzyme-linked immunosorbent assay • EMA: European Medicines Agency • FDA: Food and Drug Administration, US • HRP: horseradish peroxidase • IU: international unit • MoA: mode of action • MRD: minimum required dilution • NAb: neutralising antibody • PK / PD: pharmacokinetic / pharmacodynamic

The Organisation for Professionals in Regulatory Affairs

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Thanks for your attention

Contact details: isabelle.cludts@mhra.gov.uk

Questions?

The Organisation for Professionals in Regulatory Affairs

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