Where pharmacokinetic (PK) analysis describes exposure to the therapeutic- what the body does with the drug – pharmacodynamic (PD) analysis describe what the drug does to the body. Biomarker analysis plays a significant role in describing the PD effects of the drug.
In many cases biomarkers are an indication of the efficacy of the drug, and such pivotal biomarker assays are subject to full characterisation, as they are involved in decision making steps in the clinical development programme. Other biomarkers are often analysed as exploratory or investigative endpoints in a clinical setting.
The current model for biomarker analysis is to determine the most suitable assay for its intended application – its context of use – and to apply a ‘fit for purpose’ approach to development and validation. Biomarker assays range from exploratory and discovery assays, that may need a simple qualitative assay, to pivotal safety biomarker assays, where a definitive / fully quantitative assay is required.
At Alderley Analytical we believe a key factor in a successful biomarker programme is an early detailed discussion of the aims and requirements of the biomarker assay with the sponsor, to ensure the design and execution of the most appropriate assay validation approach.
We offer biomarker assay development and validation employing single and multiplex assays, typically using MSD or ELISA platforms.