[对新药质量标准的技术影响]。

M Uchiyama
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引用次数: 0

摘要

卫生和福利部药事局评价司于1994年9月通报了关于为一种新药申请制定质量规格和分析方法的新准则。从国际统一和技术进步的角度,讨论了一般政策以及杂质检验、药物释放、剂量单位均匀性等问题。
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[Technical implications on the quality standard of new drugs].

New guidelines on the establishment of quality specifications and analytical methods for a new drug application were notified from the Evaluation Division of the Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, on September, 1994. General policies as well as an impurity test, drug release, and the uniformity of dosage unit are discussed from the viewpoint of international harmonization and technical advancement.

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