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新药审批方面的管理:1 新药审批所需的资料在日本,无论是生产一种新药还是进口一种新药都需要提交一份申请,并附上所需的资料,其资料内容为:A.国外的起源、发现和使用情况B.物理与化学的特性及规格C.稳定性D.毒性E.药理F.吸收、分布、代谢与排泄(ADME)G.临床研究本文的第一部分是介绍,其中特别强调药品的安全性与功效。有关吸收、分布、代谢与排泄的资料必须包括在人体中研究的资
Management of approval of new drugs: 1 Information required for approval of new drugs In Japan, whether it is for the production of a new drug or for the import of a new drug, an application must be submitted with the required information. The contents of the information are: A. Overseas Discovery, and Use B. Physical and Chemical Properties and Specifications C. Stability D. Toxicity E. Pharmacology F. Absorption, Distribution, Metabolism and Excretion (ADME) G. Clinical Studies The first part of this article is an introduction to the Special emphasis is placed on the safety and efficacy of medicines. Information on absorption, distribution, metabolism, and excretion must include information on research in the human body