Background A contract manufacturer of pharmaceuticals required bibra to peer review its Health-Based Exposure Limit (HBEL) assessments in line with European Medicines Agency (EMA) guidance (EMA, 2014). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/11/WC500177735.pdf Client A pharmaceutical contract manufacturer. Project goals The client had documented two HBEL assessments and bibra was…
Background A multi-national food manufacturing company required tabulation of key toxicological information on chemicals that may possibly be present in cleaning agents, including the most pertinent data on toxicity, health criteria values and data on exposure through food. Client A global food manufacturer. Project goals…
Background Toxicity and ecotoxicity information is continually being published and current awareness is important to responsible companies. Bibra toxicologists have many years of experience and expertise in searching the toxicological literature Client A global company in the market of active ingredients for crop protection products….
Background A pharmaceutical company requested an assessment of elemental impurities in each of two injectable drug formulations, in line with the ICH Q3 Guideline on Elemental Impurities (EMA, 2016; ICH, 2014). Client A pharmaceutical company. Project goals Bibra was asked to evaluate, if possible, the…
Background A contract manufacturer of pharmaceuticals required an assessment of elemental impurities in a multi-component oral drug product, in line with the ICH Q3 Guideline on Elemental Impurities (EMA, 2016; ICH, 2014). Client A pharmaceutical contract manufacturer. Project goals Bibra was asked to evaluate the…
Background An e-cigarette manufacturer intends to market a novel electronic nicotine delivery system (ENDS) device as a therapeutic nicotine replacement therapy in the UK. As such, the MHRA must approve the use of this device as a medicinal product. With the support of a regulatory…
Background A multi-national company required concise summaries on mycotoxins (compounds arising from the presence of moulds in foodstuffs) and biogenic amines (nitrogenous compounds arising from food fermentation processes and/or food spoilage). These were to provide the most pertinent data on toxicology, health criteria values, levels…
Background Bibra was asked to establish a tolerable systemic exposure for a key ingredient in an oral cosmetic product. In the theoretical case that use of the cosmetic would provide the key ingredient at a dose matching the tolerable exposure, bibra was also asked to…
Background Bibra was asked to assess the likelihood that a chemical used by the client in some of its syntheses might at some point in the future be identified as a Substance of Very High Concern (SVHC) in the context of the REACH regulations. Additionally,…
Project goals Bibra was asked to evaluate the available data on the constituents of the two products with specific focus on their potential for skin sensitisation and subchronic oral toxicity. The aim was to determine whether testing of the products in laboratory animals for these…