advertisement
Abstract #26695 Published in IGR 12-3
A case study: Safety evaluation of ophthalmic drug-device combination products
Brown APInternational Journal of Toxicology 2010; 29: 118
The combination of medical devices, polymers/coatings, and pharmacologic agents is occurring, due to the integration of various technologies. In the field of ophthalmology, this is resulting in combination products for treating infectious disease, retinal disorders, glaucoma, inflammation, etc. As an example, intraocular implantation of drug-device combination products can deliver pharmacologically active compounds to the posterior portion of the eye. By doing so, this product may provide therapeutic concentrations of the active compound to ocular substructures, with minimal systemic exposure. Contact lenses impregnated with a drug may afford greater efficacy for treating conditions of the anterior portion of the eye, while correcting vision. This session will provide an overview of points to consider when conducting nonclinical safety evaluation of ophthalmic drug-device combination products, with examples provided. Topics to be presented will include toxicokinetics, ocular safety assessment, and biocompatibility of devices.
A.P. Brown. Senior Toxicologist, NAMSA, NorthwoodUnited States.
Classification:
11.16 Vehicles, delivery systems, pharmacokinetics, formulation (Part of: 11 Medical treatment)
