Module 9 2024

05/09/2024

BIOLOGICAL ANALYSIS

The Organisation for Professionals in Regulatory Affairs

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Bioassays

Bioassays are a key pillar of the Biosimilarity Exercise

CET 1

PK/PD

Nonclinical

Reducing Uncertainty 1 CET = comparative efficacy trial

Analytical

Non-clinical usually in-vitro not in-vivo

Similarity Assessment with Reference

The Organisation for Professionals in Regulatory Affairs

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