Evaluation of pharmacodynamics of drugs acting on the central nervous system using computer-assisted eye movement analysis.

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Computer-assisted eye movement analysis (C-EMA) seems to be a useful tool to clarify relationship between pharmacokinetics (PK) and pharmacodynamics (PD) of drugs acting on the central nervous system (CNS). We evaluated PK/PD of nitrazepam, widely used antianxiety, by using C-EMA system. 1. Eight volunteers participated in a double-blinded randomized placebo controlled study in a crossover fashion. Saccadic peak velocity (SPV) was significantly reduced by nitrazepam treatment. No significant effect was observed for smooth pursuit eye movement (SPEM). 2. Gender differences in PK/PD of nitrazepam were studied with 8 female and 8 male volunteers in a placebo controlled double blind crossover trial. SPV significantly decreased in both groups. Basic values of SPEM were significantly lower in a female group. 3. Ethnic difference in PK/PD of nitrazepam was studied with age and gender matched 8 Caucasians and 8 Japanese subjects by C-EMA.No differences were observed for PK/PD of nitrazepam in both ethnic groups. 4. Effect of menstrual cycle on C-EMA was evaluated in 8 female volunteers. SPV and SPEM did not differ during 2 menstrual cycles. We concluded that C-EMA is a useful tool for evaluating drugs acting on the CNS because of its sensitive, simple, and reproducible features.'