title: An approach to the validation of biomarkers of harm for use in a tobacco context.
abstract: There is both a call and a need for biomarkers of harm that are validated for use in a tobacco context. Currently, there are no validated biomarkers and there is no consensus about which ones may be suitable for this purpose. To advance the science in this area a working definition of biomarkers of harm and a shortlist of candidate biomarkers are proposed. A framework for the validation of biomarkers of harm using of a series of epidemiological studies culminating in a targeted prospective study is outlined. The candidate biomarkers have advanced to preliminary testing although this does not imply that any on the shortlist will become validated. This framework could also be used for the evaluation of proteomic, genomic, transcriptosomic or metabonomic profiles, which may turn out to be the preferred biomarkers for use in harm prediction. Biomarker studies would complement data that are generated from specific in vitro tests and from animal studies to evaluate tobacco products.
authors.affiliation: ENI Limited, 2 Hill House Court, Pattishall, Northants NN12 8JN, UK. infoENI@aol.com
authors.forename: E O
authors.initials: EO
authors.lastname: Gregg
authors.forename: A-L
authors.initials: AL
authors.lastname: Fisher
authors.forename: F
authors.initials: F
authors.lastname: Lowe
authors.forename: M
authors.initials: M
authors.lastname: McEwan
authors.forename: E D
authors.initials: ED
authors.lastname: Massey
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000032:analysis; D002318:Cardiovascular Diseases / Q000209:etiology; D004784:Environmental Monitoring; D004785:Environmental Pollutants / Q000032:analysis*; D006801:Humans; D009369:Neoplasms / Q000209:etiology; D018570:Risk Assessment; D012907:Smoking / Q000009:adverse effects; D014481:United States; D062789:Tobacco Products
chemical_list: D015415:Biomarkers; D004785:Environmental Pollutants