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Biomarkers as drug development tools: discovery, validation, qualification and use
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- Understanding post-market surveillance requirements for medical devices (US & EU markets)
- Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics
- Biomarkers as drug development tools: discovery, validation, qualification and use
- Clinical Biomarkers in Drug Discovery and Development
- Non-Inferiority Clinical Trials to Establish Effectiveness
- FDA Approval Process
- Three tools that help medical device SMBs work remotely
[/vc_column_text][/vc_tta_section][vc_tta_section title=”Pharmaceutical Industry” tab_id=”1627980937187-b924660b-9a68″ el_class=”cliniresearch”][/vc_tta_section][vc_tta_section title=”Diagnostic Providers” tab_id=”1627980969544-2859d88f-69b8″ el_class=”cliniresearch”][/vc_tta_section][vc_tta_section title=”Therapeutic Providers” tab_id=”1627980990631-e159321b-e39c” el_class=”cliniresearch”][/vc_tta_section][/vc_tta_accordion][/vc_column][vc_column width=”2/3″][vc_row_inner][vc_column_inner width=”1/2″][/vc_column_inner][vc_column_inner width=”1/2″][vc_column_text]
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Biomarkers as drug development tools: discovery, validation, qualification and use
[/vc_column_text][vc_column_text]The formation of the national Precision Medicine Initiative and the expansion of efforts to address illness prevention, diagnosis, and treatment based on molecular knowledge of disease were supported by the United States’ 21st Century Cures Act, passed in December 2016. The Act codifies the FDA’s official procedure for qualifying drug development tools, such as biomarkers and clinical outcome evaluations, to improve clinical trial efficiency and shape the future of molecular medicine. For the certification of biomarkers intended for use as companion diagnostics or the development and regulatory approval of a medication or treatment, the FDA and the European Medicines Agency (EMA) have devised comparable methods. Biomarkers employed just for diagnosing, monitoring, or stratification patients in clinical trials are not subject to regulatory approval, even though their qualification can help with the trial’s conduct.[/vc_column_text][vc_column_text]The critical characteristics of biomarker discovery, analytical validation, clinical qualification, and usage are explained to provide readers with a better knowledge of the process of biomarker creation and, as a result, a better comprehension of their possible benefits and drawbacks.
When conventional trial and error approaches to medicine are replaced with treatment based on molecular diagnostics, a change that is especially noticeable in cancer. The ability to offer customized health care is enabled by identifying disease phenotypes: selecting the correct therapy for the right patient. Biomarkers are critical for identifying disease phenotypes and drug development, particularly for medicines that target specific disease phenotypes. Drug development has become more complex and resource-intensive in recent years.[/vc_column_text][vc_column_text]
References
Kraus, Virginia B. “Biomarkers as drug development tools: discovery, validation, qualification and use.” Nature Reviews Rheumatology 14.6 (2018): 354-362.
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