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Clinical Studies
for Nicotine Products

Generating clinical data to support the potential benefits of novel nicotine delivery products

Whatever type of novel nicotine product you are developing, clinical data illustrating the potential benefit of your innovation when compared to smoking a combustible cigarette will be essential to obtain regulatory approval and market authorization.  Working with the right experts to plan, design and execute appropriate clinical studies is essential to the commercial realization of your project.


stethoscope and lung x-ray

Why are Clinical Studies Important?

Clinical studies for nicotine delivery products help build the evidence base to demonstrate likely benefits for smokers who choose to use the product instead of smoking.

While pre-clinical studies can show that these nicotine products generate fewer harmful chemicals and demonstrate less toxicological concern than combustible cigarettes, it is essential to note that pre-clinical data is generated by machines under defined puffing regimens. Clinical studies are necessary to understand if the reduction in toxicity seen in the lab, translates when people use the product considering their highly personal puffing behavior that differs from person to person.

Clinical studies can be designed to measure the generation of harmful chemicals and the resultant toxicological burden based on actual product use. They measure nicotine and other potentially harmful chemicals levels in the user’s body.

Whatever type of nicotine delivery product you are developing, our clinical study experts can support study design, study delivery, data interpretation, and the compilation of regulatory submissions. Our scientists have experience across the broadest possible range of nicotine delivery products. 

  • E-cigarettes and E-liquids
  • Heated Tobacco Products
  • Modern Oral Nicotine Pouches
  • Nicotine Replacement Therapies 
  • New Nicotine Delivery Innovations

Speak to a clinical studies expert to learn more about the importance of gathering clinical studies data to improve product understanding and support a regulatory submission. 

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Designing the Best Clinical Study Program

Planning and designing suitable clinical studies to generate the data necessary to meet your commercial objectives and regulatory requirements will depend on the regulatory pathway you select for your novel nicotine product.  Our chemists and clinical study scientists will work with your in-house team during an in-depth strategy definition phase to decide the study program most appropriate for your needs.  There are four vital clinical studies to support research into how well a novel nicotine delivery product works for people. 

Our Clinical Studies Support Services

Topography Studies

Designed to understand the puffing use behavior when subjects use an electronic nicotine delivery device or heated tobacco product. Parameters such as puff volume, puff duration, peak airflow, and inter-puff intervals are measured to understand if the product is used differently from the standards used in the laboratory. The data from these studies can also be used in desk-based toxicological assessments as a more accurate “dose” can be determined to calculate the product's toxicological risk.

Pharmacokinetic (PK) and Pharmacodynamic (PD) studies

PK/PD studies are essential data points in regulatory applications. They provide information that indicates how much nicotine is delivered to the user by assessing the levels of nicotine in the blood compared to the levels detectable after smoking a combustible cigarette. Several PK parameters are considered for assessing the data and product.

PD data relies on validated satisfaction questionnaires. The product should demonstrate levels of satisfaction similar to a combustible cigarette to ensure that smokers can achieve sufficient satisfaction to off-ramp from using a conventional tobacco product.

Biomarker of Exposure (BoE) Studies

These studies look at understanding the efficacy of a novel nicotine delivery product by analyzing changes in the blood, urine, and physiology. Biomarkers of Exposure (BoE) are generally metabolic products of the Harmful and Potentially Harmful Constituents (HPHCs) found in cigarette smoke. Since the laboratory analysis likely shows a reduction or elimination of the HPHCs compared to combustible cigarettes, BoE Studies look to provide clinical confirmation that exposure to HPHCs is reduced. 

BoE studies can either be conducted over a short duration (5 days) when subjects stay in a clinic and their exposures to other sources of the HPHCs are controlled or be longer ambulatory studies (up to 6 months) where subjects use the product at home in the real world. The most robust applications use a combination of both approaches to show the reductions in both controlled and uncontrolled environments.

Biomarkers of Potential Harm (BoPH)

BoPH are associated with smoking-related disease endpoints such as lung function, blood pressure, and inflammation. These studies are designed to show that prolonged use of the novel nicotine delivery product instead of combustible cigarettes results in changes in these biomarkers, indicating a reduction in the risk of disease development. 

BoPH studies usually last 12-18 months, as these biomarkers need a more extended period to demonstrate change because of stopping or reducing smoking combustible cigarettes. These types of studies are typically only required for MRTP applications.

Nicotine Consultancy Services Resources 

Learn more about how we can help bring your nicotine delivery product to market through our scientific and regulatory consultancy services.


Next Generation Nicotine Products Service Guide

We help companies of all sizes through the product lifecycle stages, from concept innovation, product realization, and regulatory submission to post marketing surveillance. 

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Strategic Insights to reignite PMTA confidence

Broughton share their thoughts on how to reduce costs and protect timelines while continuing to innovate.

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Whitepaper: Nicotine Pouches: An Extraordinary Opportunity to support Tobacco Harm Reduction

There is no doubt that the reduced-risk industry today is at an impasse, although there is now common acceptance that combustible cigarettes are the most hazardous form of nicotine delivery due to the accompanying harmful chemicals produced from tobacco combustion.

Click to download

Nicotine Industry Insight and Expert Opinion

Learn more about our activities and gain insight from our scientific and regulatory experts

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Arrange a meeting with scientific or regulatory expert with years of nicotine industry experience to discuss your project and learn how we can help to turn regulatory compliance into a driver of business success.

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