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Biomarkers from other pathways

Biomarkers from other pathways

On-target biomarker

Figure 2 On- and off-target biomarkers of a specific mechanism of drug intervention. Possible relationship of biomarkers from a specific pathway to disease outcome. Other pathways may have common distal biomarkers that may be used as predictive index of the same disease outcome.

The application of a novel biomarker in clinical trials for the purpose of biomarker characterization is often included as a secondary objective in a clinical protocol, while toxicity and commonly recognized efficacy biomarkers may be included in the primary objectives. Characterization of a specific novel biomarker may be carried out on different new chemical entity development programs over several therapeutic areas. Therefore, it is important for the assay laboratory to have both a "big picture" perspective on the development of a certain novel biomarker and the specific purpose of the application of that biomarker in a clinical trial. The time required for biomarker assay development and method validation, the operational and logistical issues, including preanalytical factors, and the limitations in data interpretation are key elements for careful planning and execution to support biomarker development and its applications.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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