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良好实验操作规范[Good Laboratory Practice(GLP)Standards]已为全世界从事药物和生物制品安全性研究的厂家及合约承包实验室了解。 1978年,因为一家美国公司向新药申请处呈报的数据中发现有伪造数据,为了对人及动物用药、生物制剂、食品及着色添加剂、动物饲料添加剂、人用医疗器械及电子产品等材料的非临床实验研究加强管理,美国食品药品管理局新药申请处建立了他们自己的良好实验操作规范。继美国之后,经济合作发展组织(OECD)、法国、瑞士等也分别建立了各自的良好实验操作规范以控制药物和生物制剂的安全性研究。在日本,1982年由保健福利部颁布了良好实验操作规范,并于1983年4月生效。该规范应用于为申请新药的批准而进行的非临床安全性研究。
Good Laboratory Practice (GLP) Standards] are well known to manufacturers and contract laboratories around the world for drug and biological safety research. In 1978, because a U.S. company found forged data in the data reported to the New Drug Application Office, in order to treat human and animal drugs, biologics, food and coloring additives, animal feed additives, human medical devices and electronic products, etc. Clinical Laboratory Studies To strengthen management, the FDA has established its own good experimental practices. Following the United States, the Organization for Economic Co-operation and Development (OECD), France and Switzerland have also established their own good experimental practices to control the safety of pharmaceuticals and biologicals. In Japan, Good Laboratory Practices was promulgated by the Ministry of Health and Welfare in 1982 and came into effect in April 1983. This specification applies to nonclinical safety studies for the approval of new drugs.