The relevance of preclinical studies for the treatment of Parkinson's disease.
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).
Gerlach
M
M
Klinische Neurochemie, Universitätsklinik für Kinder- und Jugendpsychiatrie und Psychotherapie, Füchsleinstrasse 15, 97080 Würzburg, Germany. manfred.gerlach@mail.uni-wuerzburg.de
Foley
P
P
Riederer
P
P
D000978:Antiparkinson Agents / Q000009:adverse effects / Q000627:therapeutic use; D001577:Benzophenones / Q000627:therapeutic use; D004353:Drug Evaluation, Preclinical; D006801:Humans; D007980:Levodopa / Q000009:adverse effects / Q000627:therapeutic use*; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D009596:Nitrophenols; D010300:Parkinson Disease / Q000188:drug therapy*; D012642:Selegiline / Q000627:therapeutic use; D000077867:Tolcapone
D000978:Antiparkinson Agents; D001577:Benzophenones; D018696:Neuroprotective Agents; D009596:Nitrophenols; D012642:Selegiline; D007980:Levodopa; D000077867:Tolcapone