药物临床试验是指任何在人体(病人或健康志愿者)进行的药物的系统性研究,以证实或发现试验药物的临床、药理和/或其他药效学方面的作用、不良反应和/或吸收、分布、代谢及排泄,目的是确定试验药物的安全性和有效性。 药物临床试验一般分为I、II、III、IV期临床试验和药物生物等效性试验以及人体生物利用度。
...发表 - xzbu.com 中国论文网 关键词] 药物临床试验;质量控制;过程管理;电子化管理 [gap=930]Key words] Drug clinical trials; Quality control; Process management; Electronic management ..
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...力学;有限采样;药物临床试验;安妥沙星 [gap=1348]Keywords: pharmacokinetics; limited sampling strategy; clinical trails; antofloxacin ...
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药物临床试验管理规范 GCP
药物临床试验质量管 Good clinical practice
药物临床试验机构 GCP
考虑药物临床试验 Consider trial off drug
药物临床试验质量管理 Good clinical practice
目的:探讨在我国建立药物临床试验赔偿机制的必要性。
OBJECTIVE:To discuss the necessity of compensation system in clinical trial of medicine in China.
结论:科学、严谨的药物临床试验设计,有助于获得真实、可靠的研究结果。
CONCLUSION: Scientific and strict clinical trials of drugs are helpful to obtain actual and reliable research results.
目的分析药物临床试验中影响受试者脱落的主要因素,探讨降低受试者脱落率的管理方法。
Objective To analyze main causes of drop-out in drug clinical trial and explore the methods of management in reducing its rate.
It's--that's a very different process than testing a drug, where if you had a drug for heart disease, you would give it to patients that had heart disease and see if you had an impact.
这与药物的临床试验截然不同,如果对一种治疗心脏病的药进行临床试验,你可以将药分发给,心脏病患者并观察药效
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