A consumer health risk assessment of e-liquid containers

A consumer health risk assessment of e-liquid containers

Client A US manufacturer and supplier of container closure systems designed for e-liquids. Background In order to inform e-liquid manufacturers of any hazardous chemicals that may potentially leach from the containers into their e-liquid formulations for Premarket Tobacco Product Application (PMTA) submissions to the US…

Continue reading →

Evaluation of the endocrine-disrupting potential of two plant protection products

Evaluation of the endocrine-disrupting potential of two plant protection products

Client A regulatory and toxicology consultancy. Background Under the recent amendment to the plant protection products regulation (Regulation (EU) 2018/605), information on the potential endocrine-disrupting (ED) properties of such products must be collated and evaluated. Project goals To evaluate the ED properties of two plant…

Continue reading →

Evaluation of the endocrine-disrupting potential of two biocidal products

Evaluation of the endocrine-disrupting potential of two biocidal products

Client A regulatory consultancy, specialising in biocidal products. Background Under the recent amendment to the biocidal products regulation (Regulation (EU) 2017/2100), information on the potential endocrine-disrupting (ED) properties of such products must be collated and evaluated. Project goals To evaluate the ED properties of two…

Continue reading →

Toxicity assessment of CBD as an active pharmaceutical ingredient (API) in an inhaler device

Toxicity assessment of CBD as an active pharmaceutical ingredient (API) in an inhaler device

Client A pharmaceutical company. Background The client is interested in using CBD (cannabidiol), the major non-psychoactive component of cannabis, in a breath-operated medical inhaler device. CBD has been associated with a range of therapeutic benefits, but the current knowledge about its toxicity is something that…

Continue reading →

Toxicity review of CBD for use as a novel ingredient in e-liquids

Toxicity review of CBD for use as a novel ingredient in e-liquids

Client A manufacturer of e-cigarettes. Background The client is interested in introducing CBD (cannabidiol), the major non-psychoactive component of cannabis, as an ingredient to its e-liquids. The e-liquids are intended to be used in vaping products, which could potentially expose the lungs of consumers to…

Continue reading →

ISO 10993 risk assessment of ester extractables from a medical device

ISO 10993 risk assessment of ester extractables from a medical device

Client An analytical lab working on the behalf of a medical devices manufacturer. Background Extraction studies on a device used to transfer injectable medium identified several esters that could, as a worst case, leach over time into the contained fluid, and subsequently be injected into…

Continue reading →

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…

Continue reading →

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…

Continue reading →

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…

Continue reading →

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…

Continue reading →

Page 1 of 14 1 2 3 4 5 ... Last →