After a product has been developed and has been shown to generate lower levels of HPHCs in the aerosol compared to levels found in cigarette smoke, it undergoes Toxicological Assessment.
Toxicological Assessment tells us about how much damage to the biology of an organism the aerosol from an RRP may cause compared to cigarette smoke, and if that damage is likely to activate biological mechanisms that may result in the onset of tobacco-related diseases.
It is important to note that toxicological data on its own is not sufficient to prove that switching to smoke-free products is of reduced risk compared to continued cigarettes smoking; specially designed clinical studies are required to answer such questions. That being said, toxicological assessment provides a very good indication of the risk reduction and the confidence to move forward with clinical studies. Results from toxicological studies can also complement the data from clinical studies.
Toxicity assessment helps to predict whether a given smoke-free product is likely to present less risk of harm compared to continued smoking.
Regulatory Toxicology focuses on assessing the toxicity of our products on cells grown in the laboratory and in laboratory animals. The main purpose of Regulatory Toxicology is to provide data for regulatory agencies on whether our products meet their defined acceptability criteria. These criteria include requirements for manufacturing and are prerequisites to clinical tests. In the case of smoke-free tobacco products, the aim is to demonstrate that the toxicity of the aerosol from smoke-free products is lower than that of cigarette smoke.
Regulatory Toxicology assessment is performed under Good Laboratory Practice (GLP). GLP ensures uniformity, consistency, reliability, reproducibility, quality and integrity in the methodology of the tests and therefore the results.
Learn more about Regulatory Toxicology
Our regulatory toxicology methods and papers
PMI is at the forefront of using systems biology and applying it to toxicology. Not only do we make full use of the most advanced biological and computational techniques available today, we are also leading the development of new methods that may become the new standards of tomorrow. Furthermore, we have a very comprehensive verification program in which we share the algorithms we develop and the data generated. Using expert crowdsourcing, we make our full data sets available for scrutiny and interpretation, and actively compare the findings to our own.
Read about Systems Toxicology in depth
At the forefront of using systems biology and applying it to toxicology