In silico assessment of impurities in a pharmaceutical
Case study
The client presented us with the structures of a number of impurities in a medicine currently in development for advanced cancer indications.
REACH registration of nearly 100 related metal compounds
Case study
Manufacturers of chemicals in, or importers into, the European Union are required under the REACH regulation to submit a dossier of information on their substances to ECHA.
Summarising hazard data on food additives and contaminants
Case study
On a regular basis over a period of nearly 20 years, bibra has provided a multi-national company with first drafts, or updates, of concise reports on individual or groups of food additives and contaminants.
The identification of oral and inhalation Health Criteria Values (HCVs)
Case study
Health Criteria Values (HCVs) are expressed in different ways, using the terminology specific to the authority that is recommending them. Oral values represent a regular ingested dose that is expected to be without appreciable risk to the consumer over a lifetime.
Derivation of a dermal HBEL for a hormone ester
Case study
Health-Based Exposure Limits (HBELs) are used to control risk when different medicinal products are manufactured in shared facilities.
Cosmetic Product Safety Report (CPSR) on a skin cream
Case study
Under Regulation (EC) 1223/2009, cosmetics within the European Union should not be placed on the market if they are harmful to health under normal or reasonably foreseeable conditions of use. Bibra was asked to produce a CPSR on a skin cream with multiple ingredients.
N-Nitrosamines risk assessment for a pharmaceutical product
Case study
Bibra was asked to investigate two N-nitrosamines extracted from stoppers for vials used within the pharmaceutical sector.
PDE for a leachable in an intravenous pharmaceutical
Case study
ICH defines a Permitted Daily Exposure (PDE) as a pharmaceutically acceptable intake “protective of public health for all patient populations” and provides specific guidance on the derivation of PDEs for threshold toxins identified as residual solvents (Q3C guideline) and elemental impurities (Q3D guideline) in pharmaceuticals.
Literature monitoring for an industry group
Case study
The scientific literature can provide an early indicator of potential changes in the regulatory status of chemical substances. Organisations representing different chemical sectors may therefore provide services to their members that keep them up to date with the latest relevant publications on the toxicology of their chemicals in humans and other animals, as well as their persistence in the environment.
Evaluation of the safety of two complex cosmetics ingredients
Case study
The client was interested in extending the conditions of use of two of its manufactured surfactants to cosmetics and requested a risk assessment in order to evaluate their safety in a range of rinse-off and leave-on products. The two surfactants are each a mixture of several different structurally-related chemicals.