Projects

Service areas: Pharmaceuticals, Toxicology & Human Health Risk Assessment,

Risk Assessment of Multiple Extractables from Components of an MDI

Metered Dose Inhalers (MDIs) are manufactured from a variety of plastic or rubber materials, and over time leaching into the active substance can occur. We undertook a risk assessment to estimate risk to human health from exposure to the MDI leachables.
Find out more

Service areas: Pharmaceuticals,

Risk Assessment of HFAs used as Propellants in Autoinjector systems

We undertook a risk assessment of hydrofluoroalkanes (HFAs) exposed intradermally or subcutaneously during autoinjection in humans using a medical device. As exposure to HFAs via this pathway is uncommon, data from other exposure pathways were considered, taking into account metabolic pathways and local and systemic effects.
Find out more

Service areas: Pharmaceuticals,

Environmental risk assessment of human medicines

Client Various confidential clients Background Article 8(3) of Directive 2001/83/EC requires the submission of an evaluation of the potential environmental risks posed by medicinal products in any new marketing authorisation application. Objectives To conduct an environmental risk assessment of human medicines. Methodology Phase 1 risk assessments were undertaken according to guidance issued by the European
Find out more

Have a question?


Get in touch