Toxicological Risk Assessments: Excipients 

Our American and European Board-certified toxicologists have an extensive understanding of global regulatory and quality requirements for pharmaceutical excipients to ensure patient safety. 

Services include: 

• Evaluation of excipients that exceed route-specific levels included in regional databases/guidelines (e.g., the FDA Inactive Ingredient Database, the Natural Health Products Ingredients Database, and the Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’) and preparation of the toxicological justification to develop higher safe levels acceptable to the applicable regulatory agency 

• Conduct excipient qualification involving Permissible Daily Exposure (PDE), Tolerable Intake (TI), Acceptable Intake (AI), and Threshold of Toxicological Concern (TTC) derivations in alignment with ICH guidelines to support margin of safety calculations at the maximum daily dose 

• Specification limit evaluations and preparation of toxicological justifications which assess risk associated with the route, frequency, and magnitude of exposure