Individual
Health
OVERVIEW
The Individual Health Impact (IHI) function focuses on evaluating how tobacco and nicotine product exposure affects individual health through clinical studies conducted under regulatory clinical research guidelines, such as Good Clinical Practice (GCP) and ICH E6(R3). By generating high-quality scientific evidence on nicotine pharmacokinetics (PK), abuse liability (AL), biomarkers of exposure (BoE) and biomarkers of potential harm (BoPH), particularly during short-term switching from combustible cigarettes to alternative nicotine and tobacco products, IHI supports our FDA regulatory submissions such as pre-market and modified risk tobacco product applications by demonstrating product performance, individual health risks, and the potential to advance Tobacco Harm Reduction.
Our approach combines clinical science, in vitro toxicology, biostatistics, and regulatory science to generate robust evidence on the individual health impact of product use. We conduct studies to characterize nicotine absorption and exposure; analyze nicotine PK profiles across products; assess AL through subjective, physiological, and PK measures; and quantify BoE to nicotine and other tobacco product use-related harmful and potentially harmful constituents. Additionally, we monitor levels of BoPH in human urine or blood to identify early indicators of disease risk, such as inflammation, oxidative stress, and cardiovascular function. Throughout all studies, participant safety is prioritized through continuous monitoring, data safety oversight, and protocol-defined safeguards.
Quality management and data integrity are ensured through a risk-based approach (per ICH E6[R3] guidelines) that proactively identifies and mitigates study risks, supported by regular reviews and robust monitoring strategies that align with regulatory guidelines. Central and targeted on-site monitoring verify critical data and maintain compliance with GCP, while complete and audit-ready trial master file documentation ensures transparency. Data governance, ethics, and use of modern digital technologies follow an established framework and data integrity and traceability principles, using validated electronic systems with secure access and audit trails. Comprehensive training for clinical staff, along with rigorous vendor and laboratory qualification, proficiency testing, and method validation also are implemented to further safeguard data quality and reliability throughout the study lifecycle.
Key Study Design Features
- Our clinical research program generates reliable, human-based evidence on how alternative nicotine products perform compared with cigarettes. based evidence on how alternative nicotine products perform compared with.
- We evaluate product performance using complementary clinical designs that answer different public health questions.
- Our studies focus on adult consumers and follow strict scientific and ethical standards to ensure data integrity, and meaningful public health relevance.
- Comparative evidence is generated using commonly used tobacco and nicotine products to contextualize results.
- We measure outcomes that matter for Tobacco Harm Reduction and regulatory science.
- Our methodological rigor supports regulatory confidence and transparent public health communication.