A conceptual framework for the validation and use of biologic markers

Area of Science:

• Environmental Health Sciences
• Toxicology
• Biomarker Research

Background:

• Extensive scientific literature exists on the promise and limitations of biologic markers.
• Significant efforts are underway across sectors to advance biomarker research and application.
• There is a need to focus on research and design strategies for validating and using biologic markers.

Purpose of the Study:

• To delineate a conceptual framework for the validation and use of biologic markers.
• To expand on the continuum of events from xenobiotic exposure to clinical disease.
• To present strategies for research and marker validation.

Main Methods:

• Conceptual framework development for biomarker validation and use.
• Review of existing literature on biologic markers and their applications.
• Presentation of research and design strategies for marker validation.

Main Results:

• A conceptual framework for biologic marker validation and use is delineated.
• The continuum from xenobiotic exposure to disease is expanded.
• Strategies for research and marker validation are presented.

Conclusions:

• Biologic markers are crucial for understanding xenobiotic exposures and resultant health impairments.
• Biomarkers are valuable in etiologic research, secondary disease prevention, risk assessment, and evaluating environmental controls.
• The proposed framework supports the advancement of biomarker science and application.