Biomarkers and Clinical Toxicology

Education

Regulation

Biological Markers or Biomarkers are characteristics that are objectively measured and evaluated as indicators of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (Biomarker Definitions Working Group - 1998).

Uses of Biomarkers include:

Pre-development studies;
Correlate with diagnosis and prognosis
Investigate pathophysiologic mechanisms

Pre-clinical studies;
Confirm activity IN VIVO
Explore concentration-response relationships

Phase I-II clinical studies;
Evaluate activity
Develop dose-response relationships

Phase III clinical studies;
Stratifying study populations
Conducting interim analysis of efficacy/safety
Applied toward regulatory approval

Clinical practice;
Establish diagnosis
Monitor treatment response
Use as prognostic or predictive measure

Uses of emerging technologies:

•Develop and apply analytical tools to discover small molecular markers to assess drug toxicity
Utilize imaging technologies to understand toxicology mechanisms at the molecular, whole organ, and whole body level
Expand application of cDNA array technologies and proteomics
Clinical technologies – less invasive tools
Use of humanized transgenic animal models to evaluate ADME and molecular/tissue/organ specific toxicity

There is ongoing research on various biomarkers in several fields such as Cancer Biomarkers, PET ligands for neuroimaging, Diabetes markers, Immunomodulatory markers, Cardiovascular markers, Hematologic disorders, Toxicity markers and Chronic lung disease.

Source: United States National Institute of Health

Attention: open in a new window.