{"title":"[对新药质量标准的技术影响]。","authors":"M Uchiyama","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":11656,"journal":{"name":"Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"1995-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Technical implications on the quality standard of new drugs].\",\"authors\":\"M Uchiyama\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":11656,\"journal\":{\"name\":\"Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"1995-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
[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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