Clinical Science
Altria’s Clinical Science team conducts studies in human volunteers (21+ and tobacco users) to assess pharmacokinetics, pharmacodynamics, tobacco constituent exposure and changes in potential indicators of disease risk during use of tobacco products to support the product applications we submit to the Food and Drug Administration (FDA).
As part of a comprehensive harm reduction strategy, Altria assesses human impact through clinical trials. This data not only helps us understand the reduced-risk potential of tobacco products, but it also helps us address FDA guidance for product applications or specific questions from FDA about our products.
We conduct studies to understand the rate and overall uptake of nicotine (pharmacokinetics) from our tobacco products.
Pharmacokinetic studies typically involve measuring nicotine blood levels over the course of a tobacco product use session. During these assessments, we also measure subjective responses about how the products are impacting tobacco cravings, the overall experience the participating adult smoker is having (pharmacodynamics).
The combination of understanding the nicotine uptake and the overall experience is used to address abuse liability of the products, which is required by the FDA, and helps evaluate the potential for new products to replace cigarettes.
Watch Dr. Edmiston discuss the role Clinical Science plays in new products research.
Review some recent posters, presentations and publications:
- Evaluation of Switching from Cigarette Smoking to Nicotine Pouches on Oral Health.
- A Randomized, Controlled, Open-label, In-clinic Study Evaluating Changes in Biomarkers of Exposure in Adult Smokers Who Switch to on! ® Nicotine Pouches for Seven Days.
- A Randomized, Controlled Study to Assess Biomarkers of Exposure in Adult Smokers Switching to Oral Nicotine Products.
View more posters and presentations here.
