Gerlach M, Foley P, Riederer P
Klinische Neurochemie, Universitätsklinik für Kinder- und Jugendpsychiatrie und Psychotherapie, Füchsleinstrasse 15, 97080 Würzburg, Germany.
J Neurol. 2003 Feb;250 Suppl 1:I31-4. doi: 10.1007/s00415-003-1106-y.
An essential element of pharmaceutical development, defined as the period between the discovery of a new agent and its market release, is provided by the "preclinical studies". They consist of the in vitro and in vivo studies performed before examination of the agent in human subjects. Regulatory authorities prescribe specific requirements regarding the nature and number of preclinical studies. In the present paper, we discuss the relevance of these studies for the treatment of Parkinson's disease (PD) on the basis of three examples: the L-DOPA ( L-3,4-dihydroxyphenylalanine, levodopa) story; the development of selegiline as a palliative and neuroprotective drug; and the safety concerns regarding tolcapone, an inhibitor of central and peripheral catechol-O-methyltransferase (COMT).
药物研发的一个关键要素是“临床前研究”，它被定义为从发现新药物到其上市之间的阶段。临床前研究包括在人体试验之前进行的体外和体内研究。监管机构对临床前研究的性质和数量规定了具体要求。在本文中，我们基于三个例子讨论这些研究对帕金森病（PD）治疗的相关性：左旋多巴（L-3,4-二羟基苯丙氨酸，左多巴）的故事；司来吉兰作为一种姑息性和神经保护药物的研发；以及关于托卡朋（一种中枢和外周儿茶酚-O-甲基转移酶（COMT）抑制剂）的安全性问题。
