Acceptable intake for an impurity in a new anticancer drug

Acceptable intake for an impurity in a new anticancer drug

Client A pharmaceutical company. Background A possible impurity was identified in the development of a new anticancer drug. Project goals Bibra was asked to conduct Leadscope analyses on this impurity to assess its genotoxic/mutagenic potential and to subsequently classify it in line with ICH guideline…

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Health risk assessment of a nicotine salt

Health risk assessment of a nicotine salt

Background Nicotine can be added to e-liquids either in its basic form or as a nicotine salt. Bibra was approached by a client interested in assessing the use of a particular salt as a source of nicotine in one of its e-liquid products. Client A…

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Health risk assessment of impurities in a nasal spray device

Health risk assessment of impurities in a nasal spray device

Client A pharmaceuticals manufacturer. Background A partially characterised impurity (refined to one of two isomers) was identified in a nasal drug product after storage under exaggerated conditions. Project goals Bibra was asked to evaluate the toxicological risks posed to patients by one or other (or…

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Human health risk assessment of skin patch leachables in artificial sweat

Human health risk assessment of skin patch leachables in artificial sweat

Client An analytical laboratory working on behalf of a pharmaceuticals manufacturer. Background A number of organic chemicals were detected in artificial sweat tests on a skin patch designed to supply an anaesthetic to patients. Some of these were found at levels above the relevant analytical…

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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)…

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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…

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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…

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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…

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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…

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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…

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