An overview of drug development with special emphasis on the role of visual electrophysiological testing

被引:10
作者
Brigell, M
Dong, CJ
Rosolen, S
Tzekov, R
机构
[1] Pfizer Global Res & Dev, Clin Technol, Ann Arbor, MI USA
[2] Allergan Pharmaceut Inc, Dept Biol Sci, Irvine, CA USA
[3] INSERM, U592, Paris, France
关键词
clinical trial; drug development; electroretinogram; visual evoked potential;
D O I
10.1007/s10633-005-7338-9
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
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.
引用
收藏
页码:3 / 13
页数:11
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