title: An overview of drug development with special emphasis on the role of visual electrophysiological testing.
abstract: Visual electrophysiological techniques, such as electroretinography (ERG) and visual evoked potentials (VEP) can provide useful information on the safety, efficacy, and proper dosing of chemical entities under development as new drug therapies. During post-marketing safety surveillance, a variety of visual electrophysiological measures can be used to objectively assess and document individual patient response to ophthalmic drugs and ocular or visual system side effects of non-ophthalmic drugs. In this paper, the discovery, exploratory development, full-development and post-marketing stages of drug development are briefly outlined. The potential role of visual electrophysiological techniques in each of these stages is described and discussed.
authors.affiliation: Clinical Technology, Pfizer Global Research & Development, 2800 Plymouth Road, Ann Arbor, MI 48105, USA. mitchell.brigell@pfizer.com
authors.forename: Mitchell
authors.initials: M
authors.lastname: Brigell
authors.forename: Cun-Jian
authors.initials: CJ
authors.lastname: Dong
authors.forename: Serge
authors.initials: S
authors.lastname: Rosolen
authors.forename: Radouil
authors.initials: R
authors.lastname: Tzekov
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D004341:Drug Evaluation / Q000379:methods*; D004585:Electrooculography; D004596:Electroretinography; D005074:Evoked Potentials, Visual; D005128:Eye Diseases / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D009900:Optic Nerve / Q000187:drug effects / Q000503:physiopathology; D004364:Pharmaceutical Preparations; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012160:Retina / Q000187:drug effects / Q000503:physiopathology
chemical_list: D004364:Pharmaceutical Preparations