TABLE 11–1 Exposure and Biomarker Assessment Definitions

Exposure or Biomarker Assessmenta


External exposure marker

A tobacco constituent or product that may reach or is at the portal of entry to the body

Biomarker of exposure

A tobacco constituent or metabolite that is measured in a biological fluid or tissue that has the potential to interact with a biological macromolecule; sometimes considered a measure of internal dose

Biologically Effective Dose (BED)

The amount that a tobacco constituent or metabolite binds to or alters a macromolecule; estimates of the BED might be performed in surrogate tissues

Biomarker of potential harm

A measurement of an effect due to exposure; these include early biological effects, alterations in morphology, structure, or function, and clinical symptoms consistent with harm; also includes “preclinical changes”

aCategories and definitions reflect concept that the critical exposure is at the level of a biological macromolecule, so that exposure for this discussion is not limited to a measurement at the portal of entry to the body.

well as different approaches needed for PREP evaluation lead to a need for clarification and redefinition. The latter three measurements improve upon the first by quantifying exposure at the cellular level to characterize low-dose exposures or low-risk populations, providing a relative contribution of individual chemical carcinogens from complex mixtures and estimating total burden of a particular exposure where there are many sources (Vineis and Porta, 1996). In assessing PREPs through biomarkers, understanding the biological effects of a wide range of exposures will be important. Within the context of this chapter, exposure at the level of the cell and critical macromolecules is considered with greater weight, rather than the traditional view of exposure at the portal of entry into a person.

Biomarkers are intuitively more informative and better disease risk markers when measured in the target tissue through biopsies (e.g., oral mucosa, lung, bladder). However, biomarker assays are technically limited, and target tissue can be difficult to obtain, especially in nondiseased smokers. Therefore, biomarker assays have been developed for surrogate tissues and fluids (e.g., expired breath, saliva, blood, urine). While these are technically simpler to use and easier to collect, the ability to prove a

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