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Biomarker Applications in Drug Discovery and Development
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- The Real-Time Oncology Review (RTOR) Pilot Program for New Molecular Entities Approvals
- FDA Guidance for Human Gene Therapy for Hemophilia A & B
- Patient Centricity in Clinical Trials
- How to improve your chances of getting FDA approval
- Biomarker Applications in Drug Discovery and Development
- Risk-based monitoring in clinical research
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Biomarker Applications in Drug Discovery and Development
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- Biomarkers allow for the classification of patient groups and the quantification of how well novel medicines reach their intended targets, modify postulated pathophysiological pathways, and achieve therapeutic results. The biomarker challenge is to discover unique chemical fingerprints in complex biological mixtures associated with natural processes to verify novel drug targets and predict treatment response. To guide regulatory and therapeutic decision-making about candidate medicines and their indications, clinically relevant biomarkers are necessary.
- Disease biomarkers are crucial in medicine, and they’re starting to play a more significant role in drug discovery and development. The goal of biomarkers is to enable earlier and more reliable medication safety and effectiveness assessments. For the foreseeable future, their involvement in medication development will continue to expand. More excellent knowledge of disease development and therapeutic intervention is required for biomarkers to play their proper function. Furthermore, there is a need for a better understanding of the needs for biomarker selection and validation, biomarker assay technique validation and application, and clinical endpoint validation and application.
- The collaborative approach reduces the risk of the minor influential component causing the entire process to fail. As the scientific/regulatory foundations for biomarkers in medicine and drug development begin to be established, successes and applications will need to be effectively communicated with all stakeholders, including internal and external drug developers and regulators, as well as the medical community, to ensure that biomarkers are fully integrated into drug discovery and development as a whole.
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References
Frank, Richard, and Richard Hargreaves. “Clinical biomarkers in drug discovery and development.” Nature reviews Drug discovery 2.7 (2003): 566-580.[/vc_column_text][/vc_column][/vc_row]
