Consideration of HCV data on two substances present in food

Consideration of HCV data on two substances present in food

Background The client was interested in decisions made by the Scientific Committee for Food (SCF) on two food constituents (one a single chemical, the other a group) in the 1990s, which have not since been updated. For the single chemical, no acceptable daily intake (ADI)…

Continue reading →

Safety evaluation of an ink in a wound dressing

Safety evaluation of an ink in a wound dressing

Background The client manufactures a wound dressing which is printed with an ink comprising several chemical substances. Client A leading manufacturer of wound care and surgical products. Project goals To identify and briefly review the critical published studies relating to the toxicity of ten potential…

Continue reading →

HCV calculations for a packaging leachable based on its parent compound

HCV calculations for a packaging leachable based on its parent compound

Background Bibra was asked to derive health criteria values (HCVs) for short-term and long-term exposure to a potential leachable from the packaging of an intravenous pharmaceutical. The leachable also happens to be a key metabolite of a well-studied food additive. Client A pharmaceutical company. Project goals To…

Continue reading →

Preparation of a large number of toxicity monographs for a range of consumer-product ingredients

Preparation of a large number of toxicity monographs for a range of consumer-product ingredients

Background It is mandatory for manufacturers to perform human health risk assessments for their products to ensure the safety of the exposed workforce and consumer. In order to do this a toxicological assessment of all the ingredients used to produce the products is required. The…

Continue reading →

Peer review of two HBEL assessments

Peer review of two HBEL assessments

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…

Continue reading →

Tabulated brief toxicological overviews of chemicals potentially present in cleaning agents

Tabulated brief toxicological overviews of chemicals potentially present in cleaning agents

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…

Continue reading →

Literature monitoring for (eco)toxicity data on plant protection products

Literature monitoring for (eco)toxicity data on plant protection products

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….

Continue reading →

Strategic advice regarding the health risk assessment/risk management of elemental impurities in two injectable drug products

Strategic advice regarding the health risk assessment/risk management of elemental impurities in two injectable drug 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…

Continue reading →

Health risk assessment of elemental impurities in an oral drug product

Health risk assessment of elemental impurities in an oral drug product

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…

Continue reading →

Toxicological overview for a medicinal nicotine replacement device (MHRA submission)

Toxicological overview for a medicinal nicotine replacement device (MHRA submission)

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…

Continue reading →

Page 3 of 15 1 2 3 4 5 ... Last →