We are experienced searchers
Our scientists know that a robust risk assessment relies upon quality data. We are experienced searchers of the major toxicity literature databases, databanks and internet. In addition, our in-house database, TRACE, gives us valuable access to Expert Group and primary reports that are not reliably identified via searches the usual range of data sources. All of the documents on TRACE have been selected and indexed by our expert toxicologists, ensuring chemical-specific, reliable and highly efficient retrieval of relevant information. This unique combination is a key part of nearly every project we work on, and the details of our search methods are described in resulting reports with a high degree of transparency.
Identifying search terms
We have years of experience in selecting and using search terms likely to be relevant to a client’s areas of interest, potentially saving a great deal of time that would otherwise be spent trawling through irrelevant hits. Searches of TRACE, in particular, can be focused with just a few clicks, providing a much more relevant output than comparable external databases.
Read-across
Data-poor target compounds may have data-rich structural analogues or metabolites/ precursors. With a robust read-across approach based on surrogate data, the use of Threshold of Toxicological Concern (TTC)-based risk assessments or laboratory testing on the target compound can be avoided. Our extensive expertise in this area allows us to assess and justify the relevance of read-across compounds in providing toxicological insights. We routinely run parallel literature searches on target and read-across compounds and provide a comprehensive data matrix containing the resultant bibliographic details.
Literature search strategies & sources
When it comes to searching for toxicity data, we are ideally placed to help. For decades, we have performed searches of a tried-and-tested series of external databases (including some subscription-only packages) using searching strategies tailored to a sector. Our literature-searching skills (along with our extensive evaluation expertise) are invaluable in conducting full reviews for any chemical substance.
Literature monitoring
In addition to performing one-off literature searches for use in health risk assessments, we offer a “current awareness” literature monitoring service, sometimes known as Selective Dissemination of Information (SDI) service. We carry out regular searches, at requested intervals, of an agreed range of data sources, for new toxicity data on substances of commercial or research importance to specific clients. Together with our Toxicology and Regulatory News, this ensures that always have the most relevant literature at their fingertips for continued regulatory compliance and knowledge of changes within the industry. Literature monitoring can be broken down by:
- Global
- Local
- Ad hoc
Some of our case studies in this area
Determining a Specific Migration Limit (SML) for a data-deficient compound identified in food labels
Case study
The client was informed by a supplier that a chemical compound with a worrying structure was present within a food label ink. Click to find out how we dealt with it.
Pod-based ENDS device PMTA assessments
Case study
As part of a Premarket Tobacco Product Application (PMTA) for a pod-based ENDS device, bibra was asked to provide support preparing non-clinical and human health impact assessments.
ISO 18562 evaluation of a medical device in contact with the breathing gas pathway
Case study
As part of a large programme of work in evaluating the safety of a new endotracheal tube device, bibra was asked to evaluate the health risks posed by exposure to potentially hazardous substances that may be transferred to the patient via the gas stream during device use.
