1. Biomarkers are substances, structures, or processes that can be measured in biological samples such as urine, blood, or saliva. A biomarker is a measurable characteristic in a biological system that changes due to disease, exposure to chemicals, or exposure to organisms.
2. Biochemical biomarkers are often used in diagnostic testing where they are derived from bodily fluids that are easily available to the early phase researchers.
3. Biomarkers are often cheaper, easier & faster to measure.
4. Biomarker can be used at any point in the diagnostic chain, at the molecular, cellular, or organ level.
5. Biomarkers have always been important in clinical development and provide the most practical means of demonstrating that a candidate drug is safe and effective in a disease target population.
6. Surrogate endpoints are markers of biological mechanisms (i.e., biomarkers) that predict a clinical benefit, substitute for a clinical endpoint, and provide a mechanistic view on diseases (i.e., direct measurement of how a patient feels, functions, or survives).
7. Randomized, blinded, controlled clinical trials with definitive endpoints represent the gold standard by which new vaccines and drugs are judged.
8. Biomarkers have proven to be cost-effective and reliable for the purpose of monitoring, developing, and predicting efficacies for both drugs and vaccines.
9. Current regulations permit the FDA to base the approval of a drug on a determination of the effect the drug has on a validated surrogate marker.
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