Brigell Mitchell, Dong Cun-Jian, Rosolen Serge, Tzekov Radouil
Clinical Technology, Pfizer Global Research & Development, 2800 Plymouth Road, Ann Arbor, MI 48105, USA.
Doc Ophthalmol. 2005 Jan;110(1):3-13. doi: 10.1007/s10633-005-7338-9.
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.
视觉电生理技术,如视网膜电图(ERG)和视觉诱发电位(VEP),可为正在研发的作为新药疗法的化学实体的安全性、有效性和适当剂量提供有用信息。在上市后安全监测期间,可使用多种视觉电生理测量方法来客观评估和记录个体患者对眼科药物的反应以及非眼科药物的眼部或视觉系统副作用。本文简要概述了药物研发的发现、探索性开发、全面开发和上市后阶段。描述并讨论了视觉电生理技术在这些阶段中各自的潜在作用。