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In tobacco studies, biomarkers to assess exposure to tobacco products and biomarkers of potential harm are both of interest.

Biomarkers of exposure These biomarkers are used to characterize exposure to constituents present in tobacco products (such as harmful and potentially harmful constituents (HPHCs) and to determine the potential health impact from use of these products. These biomarkers could be indicative of exposure to tobacco products or could be related to diet or environmental exposure.

Biomarkers of exposure may be the constituents or their metabolites.

• Biomarkers of Exposure
  • metabolites of  compounds derived from cigarette smoke or other tobacco products
• Biomarkers of Potential Harm
  • indicative of healthy vs disease states
  • may look for improvement of health by way of changes over time
• Functional Endpoint biomarkers
  • cardiac function
  • respiratory system function

24 hour urine collected by sponsor (volume represented here)→ Urine aliquots sent to lab→ testing done→ results sent to sponsor (units of conc)→ sponsor converts to units/24hr  

The FDA has established a list of harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke. Additionally,  a list of 20 HPHCs from the full list of HPHCs, for which testing methods are well established and widely available. These HPHC list focuses on chemicals that are linked to the five most serious health effects of tobacco use (cancer, cardiovascular disease, respiratory effects, reproductive problems, and addiction.) 

Biomarkers of exposure may be the constituents or their metabolites. results normalized to creatinine