Human studies are a pivotal component in the submission of a PMTA/MRTP to the US Food and Drug Administration and to the European regulatory agencies for an MAA. Broughton Nicotine Services provide an end-to-end support service with specialists at the forefront of the NGPs field as well as an extensive network of experienced clinical trials facilities to ensure the study design, conduct and data interpretation are aligned with the expectation of global regulators.

The key areas that we focus on are:

• Performing clinical studies to assess puffing profiles of inhaled NGPs and nicotine uptake and abuse liability across all categories of NGPs
• Conducting rigorous literature reviews to assess the potential health impact of NGPs, to help you and the regulator position your product comparatively
• Undertaking behavioural studies to assess the prevalence of use, perceptions of use, appeal, and intentions to use NGPs in nationally representative samples of the US population
• Performing human factors studies to assess whether people understand how to use the products, that its use presents no immediate safety concerns and that any potential hazards are mitigated

Several different types of human studies are required to demonstrate that the marketing of an NGP is likely to promote the wellbeing of current smokers. The overall aim of these studies is to demonstrate that an NGP poses less safety or health risks to users compared to smoking combustible cigarettes, and that a particular product's appeal is towards its target user and not towards unintended users.

Broughton Nicotine Services provide a turn-key service in the design, conduct and reporting of human studies in four core areas:

Clinical Studies

• Nicotine pharmacokinetics – how much nicotine is delivered and how quickly when someone uses an NGP product
• Abuse liability assessment – how addictive is an NGP product relative to combustible cigarettes
• Puffing topography – for inhalable NGPs, what are the puffing patterns in users of the product, and how does this impact inhalation of toxicants and impact on health

Literature Reviews

• Rigorous assessment of whether the use of an individual or a type of NGP product is known to impact human health

Behavioural Studies

• Cross-sectional, large-scale surveys to assess the prevalence of use and demographics of users of an NGP, and what was their prior use of other tobacco and nicotine products
• Assessments of whether an NGP, its packaging, or its marketing appeal to current users of tobacco products, and whether it appeals to unintended populations such as non-tobacco users or adolescents
• Longitudinal user surveys to examine changes in tobacco product use behaviour after starting to use an NGP

Human Factors Studies

• Simulated use studies to assess whether an NGP can be used safely and operated correctly by both naive and experienced users
• Examination of whether the instructions for use of an NGP can be understood and that this leads to its safe use as intended

Broughton Nicotine services integrates all the information gathered by these studies to generate a narrative in a PMTA submission, which demonstrates whether the marketing of an NGP is Appropriate for the Protection of Public Health (APPH).

Broughton Nicotine Services offer a wide range of services, combined with a network of internal experts and partners, exclusively dedicated to supporting companies operating in the NGPs sector. This full-service, when integrated with our other NGP-focused scientific services, supports regulatory submissions and enables new product development to advance a smoke-free future.