Pharmaceuticals
Our work
Our team has many years of experience in preparing toxicological assessments required in the pharmaceutical sector. We regularly provide our clients with assessments of novel or unexpected impurities, excipients and other intentionally-added substances, and extractables and leachables.
Actives
Companies are required to generate an enormous array of data on their APIs. We are expert in summarising toxicity, ADME and pharmacology data. We also work closely with specialists in regulatory affairs and, together, we can assist in preparing the non-clinical sections of a dossier for submission.
Impurities
The toxicological assessment of impurities in pharmaceutical products poses a particular challenge as, in most cases, no substance-specific data exist. We have developed a workflow to combine our extensive expertise with in silico ((Q)SAR) models and Threshold of Toxicological Concern (TTC) concepts to establish the safety of pharmaceutical impurities.
Extractables and Leachables
A thorough assessment of potential extractable and leachable substances arising in drug products from containers and packaging is another key requirement. We have long-standing partnerships with several high-quality analytical laboratories, providing a holistic approach to the generation and evaluation of data.
Cleaning Validation
Where multiple APIs (active pharmaceutical ingredients) are produced in the same facility, it is critical to set sound toxicology-based exposure limits to ensure the safety of all pharmaceutical products. We are very experienced in following the appropriate guidance from the European Medicines Agency (EMA) and other authorities to establish these limits.
Our expertise in this area
Risk Assessment
Our health risk assessments convert the toxicological hazard profile to a health-based guidance value, and compare this reference point to an estimate of human exposure.
(Quantitative) Structure-Activity Relationships
We strive to help clients fill data gaps without a potentially costly and animal-intensive trip to the testing laboratory, by using computer models to predict the toxicological characteristics of an untested compound.
ADME/TK Assessments
Generating new TK data involves the use of animals, is time consuming and extremely costly (particularly if radiolabels are required). We make expert predictions, taking into account known toxicity data, structure and physico-chemical properties.
Some of our case studies in this area
NAMs for NGRAs
Blog articles
Traditionally, toxicological risk assessment has involved identifying a point of departure (PoD) such as a NOAEL or LOAEL in a study of small creatures, adjusting it to be relevant to humans (to derive, for example, a TI or DNEL), and then calculating the margin of safety to a measured or estimated external exposure. As part of this process, toxicologists have to account for the uncertainties that arise in moving from the species, route and duration of the laboratory animal study to the real human world.
FDA memoranda: genotoxicity and carcinogenicity assessments of ENDS
Blog articles
As discussed in a previous blog post, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has issued several “scientific policy memoranda” that provide some great insights into the Agency’s evaluation process. In June 2024, the FDA made two new memos available that relate to the genotoxicity and carcinogenicity assessment of chemical constituents of Electronic Nicotine Delivery Systems (ENDS).
FDA memoranda: shedding light on health risk assessment of ENDS in PMTA submissions
Blog articles
In 2016, the United States (US) Food and Drug Administration (FDA) ruled that Electronic Nicotine Delivery Systems (ENDS) were to be regulated just like more traditional tobacco products, meaning that ENDS (e-cigarettes and e-liquids) are subject to premarket review requirements, despite containing no tobacco. ENDS manufacturers must therefore submit a Premarket Tobacco Product Application (PMTA) to the FDA Center for Tobacco Products (CTP) in order to have any chance of legally marketing their products in the US.
