UK MAFF / Department of Health (DoH) Preparation of MAFF/DoH literature reviews covering subjects including the toxicology of polychlorinated biphenyls (PCBs), the use of toxic equivalency factors for PCBs, and the pharmacokinetics of heavy metals in infants. UK Ministry of Agriculture Fisheries and Food…
Categorization under the Canadian Environmental Protection Act (CEPA) 1999 Providing advice and critical comment on “Categorization of Organic Substances on the Domestic Substances List (DSL) for Inherent Toxicity to Humans: Proposed Initial Approach and Criteria” based on a processing of 100 compounds. Carcinogenicity and…
Co-ordination of the EU-funded Concerted Action Projects instigated to construct EUROPOEM (European Predictive Operator Exposure Model) generic databases of operator, bystander and re-entry worker exposures to plant protection products and to develop predictive models.
Contaminated land Development of toxicity collations using the principles outlined in SR2 (formerly CLR9) as part of the Contaminated Land Exposure Assessment (CLEA). As a consequence, bibra has evaluated the mammalian toxicology of a large number of substances culminating in reports that recommend oral and…
Client Kind Consumer Ltd is a UK-based healthcare research and development company focused on inhalation technologies. Kind Consumer received a Marketing Authorisation for its lead product Voke® in September 2014. Product Voke® – by Kind Consumer Ltd Background A novel nicotine replacement device was designed…
Client ECITA, the Electronic Cigarette Industry Trade Association [written with permission from ECITA] Background A wide array of flavouring substances are added to electronic cigarette formulations and these might be inhaled (along with nicotine and other excipients) by the consumer. The toxicological acceptability of such…
Client A pharmaceutical company Background A Competent Authority had asked a pharmaceutical company to prepare assessments of the potential mutagenicity/genotoxicity of five impurities in an API. Project Goals Bibra was asked to prepare critical evaluations of the genotoxicity/mutagenicity potential of these five substances. The focus…
Client A pharmaceutical company Background A pharmaceutical product based on a generic API contained two impurities at concentrations (end of shelf life) slightly higher than the ICH/EMA Quality Thresholds. Project Goals Bibra was asked to evaluate whether the higher levels of these impurities would be…
Client A pharmaceutical company Background Bibra was supplied with an analytical report on extractables and headspace studies, carried out ona container-closure system (lacquered aluminium tubes and HDPE caps) used to store an ointment for topical use. In theory, some or all of the extractables could…
Client A global producer of a range of well-known household consumer products. Background Bibra scientists were asked to review the available toxicology data on a range of specific compounds or groups of compounds that were present in the client’s products, either intentionally added or as…