title: Standardized electroretinography in primates: a non-invasive preclinical tool for predicting ocular side effects in humans.
abstract: This paper reviews the use of a standard protocol for electroretinography in drug safety evaluation studies with non-human primates. The architecture and physiology of the eye of humans and higher primates are very similar, thus making the non-human primate a preferred animal model for evaluating potential ocular side effects of drugs in humans. Using the technical and procedural features of the human protocol, i.e., the standard for clinical electroretinography (SCE), electroretinography can be routinely performed from early- to late-phases of drug development as a toxicodynamic endpoint for retinal toxicity and potential neurotoxicity in non-human primates. Hence, scientists can collect clinically relevant data using a standardized testing procedure found in the SCE. This is important in drug safety evaluations since the SCE is an established protocol that lends itself easily for incorporation into studies requiring adherence to international Good Laboratory Practice regulations. The technique is non-invasive, painless, and confers no adverse effects or damage to the eye.
authors.affiliation: Sierra Biomedical, A Charles River Company, 587 Dunn Circle, Sparks, NV 89431, USA. wbee@sierrabiomedical.com
authors.forename: W H
authors.initials: WH
authors.lastname: Bee
mesh_terms: D000818:Animals; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D004596:Electroretinography / Q000187:drug effects / Q000379:methods; D005123:Eye / Q000187:drug effects*; D000882:Haplorhini / Q000502:physiology*; D006801:Humans; D011237:Predictive Value of Tests; D013045:Species Specificity