TOXICOLOGY

Whether you’re developing a new chemical entity, a new formulation of a marketed product, or a new drug delivery system, obtaining an understanding of any potential adverse effects is critical before moving into definitive GLP studies. Powered Research has developed internal protocols for non-GLP assessment of ocular therapeutics, providing key tolerability and safety data.

Our ocular tolerability studies are conducted in rodents, rabbits, swine, or canine with various route of administration, and include standard toxicology endpoints. Additionally, all ophthalmic exams are conducted by a Board-Certified Veterinary Ophthalmologist, lending significant credibility to the results obtained.

Endpoints include:

• Cageside and detailed clinical observations

• Body weight, food consumption

• Slit lamp biomicroscopy with Hackett-McDonald scoring 

• Indirect ophthalmoscopy conducted by a Board-Certified Veterinary Ophthalmologist

• High-resolution imaging

• Tonometry, Pupillometry, Pachymetry

• Electrophysiology (ERG, VEP)

• Fluorescein angiography

• Optical coherence tomography

• Systemic pharmacokinetics (plasma, serum)

• Necropsy with macroscopic observations

• Ocular histopathology

• Immunohistochemisty