Hazard Characterisation
Our hazard assessments, generally based on in-depth searches of the scientific literature, aim to define the dose-response for all routes of each of a chemical’s toxicological propensities, for example its carcinogenicity, genotoxicity, or ability to disrupt reproduction.
We summarise all of the available data in a transparent format, taking into account the needs of our clients – for example, if there is a specific structure or format required to comply with a particular regulation.
As experienced risk assessors ourselves we are well placed to ensure that our hazard characterisation – the potential to induce a harm - provides the best possible platform the available data (and budget) will allow for any subsequent risk assessment, a judgement as to whether those harms will actually be seen in a specific circumstance.
Routes of Administration
Screening assessments
Often, we are asked to assess several compounds that could be of potential health risk to a patient. We have developed a “screening” process where we can prioritise those substances that are more likely to result in a health risk. Compounds present at very low levels, or without inherent toxic hazards, can, with appropriate justification, be excluded from further more detailed and expensive toxicological risk assessment.
(Q)SAR
More and more computational models are being developed to link a particular toxicological hazard with a chemical structure. This is called (Quantitative) Structure-Activity Relationship ((Q)SAR) modelling. When we are faced with a data-poor chemical, we routinely use (Q)SAR to generate predictions and identify possible areas of concern, or endpoints worthy of further investigation. Even the most sophisticated models still currently require a sanity check and bibra’s experienced toxicologists are ideally placed to provide it.
Safety Benchmarks
Often, a toxicological hazard characterisation is the major first step on a pathway leading to a health-based guidance value. Such a value is an estimate of the maximum exposure, generally qualified by route (parenteral, inhalation, oral or dermal), that will pose no significant threat to human health. It will usually be based on data from laboratory animal experiments, adjusted to account for the likely differences in how humans and the other species (usually a rodent) is likely to respond to chemicals in general or (much more rarely) to that specific test chemical.
Some industries we work in
Nicotine Products
We provide valuable advice on toxicological issues relating to e-cigarettes (and other nicotine delivery devices), and can support your regulatory submissions within the scope of EU TPD, UK TRPR and the US FDA PMTA.
Pharmaceuticals
Our team is adept at preparing critical toxicological reports - we regularly provide assessments of novel or unexpected impurities, excipients and other intentionally-added substances, and extractables and leachables.
Medical Devices
We are adept at conducting biocompatibility assessments and biological safety evaluations of medical devices in compliance with ISO 10993, FDA and European guidelines, to help bring your device to market.
Some of our case studies in this area
A human health risk assessment of API-related impurities
Case study
Whilst developing an inhalation spray drug product, the client identified two impurities with chemical structures related to the Active Pharmaceutical Ingredient (API). Click through to read more about how we dealt with this interesting project.
Human health risk assessment of unknown contamination
Case study
The client reported that small “brown spots” had been observed on the inside surface of a batch of aluminium tubes that contain a topical drug product. The source and chemical composition of the brown spots was unknown. Click through to read more about how we dealt with this interesting project.
Toxicological risk assessment of a disinfecting agent in a syringe medical device
Case study
The client manufactures a product which is used as part of a syringe line medical device. The connection set-up has the potential to introduce a disinfectant chemical into the line and be injected into patients. Click through to read more about how we dealt with this interesting project.
