CRED Understanding Clinical Development 2024

11/10/2024

Examples of Biomarkers

Blood components such as glucose, cytokines, CRP

Expressed receptors/ligands/markers in tissues IHC staining such as HLA typing, PD-1/PD L1

Cognitive tests for mental impairment disorders (Alzheimer's)

The Organisation for Professionals in Regulatory Affairs

17

Examples of Biomarkers

QTc prolongation – for cardiac effects of the drug

Imaging – CAT, MRI, PET for tumors, CNS effects (binding to receptors)

Pharmacogenomics – metabolism phenotype, regulation of expression, SNPs, MSI, dMMR (for cancers)

The Organisation for Professionals in Regulatory Affairs

18

9