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《药物临床试验方法学》是一本介绍临床试验管理和操作的工具书。此书由国外长期从事新药临床试验管理工作的作者撰写,内容包括国际医药管理机构对药物临床研究的指导原则和各项具体要求。
“Clinical Pharmacology Test Methodology” is a reference book on clinical trial management and operation. This book is written by foreign authors who have long been engaged in the management of clinical trials of new drugs, including the guiding principles and various specific requirements of the international medical regulatory agencies on clinical research of drugs.