漢方製剤・生薬製剤・生薬用語の英語表記
Recommended Terminology for Kampo Products,Conventional Crude Drug Products and Crude Drugs
参考文献
1) 厚生労働省, 第15改正日本薬局方, 2006, available from (http://jpdb.nihs.go.jp/jp15/).
2) The Ministry of Health, Labour and Welfare, “The Japanese Pharmacopoeia, Fifteenth Edition, English Version”, 2006, available from (http://jpdb.nihs.go.jp/jp15e/).
3) “The Japanese Standards for Herbal Medicines”, Yakuji Nippo, Tokyo, 1993.
4) World Health Organization, Regional Office for the Western Pacific, “WHO International Standard Terminologies in Traditional Medicine in the Western Pacific Region”, World Health Organization, Western Pacific Region, Manila, 2007, available from (http://www.wpro.who.int/NR/rdonlyres/14B298C6-518D-4C00-BE02-FC31EADE3791/0/WHOIST_26JUNE_FINAL.pdf).
5) World Health Organization, Regional Office for the Western Pacific, “Guidelines for the Appropriate Use of Herbal Medicines”, World Health Organization, Western Pacific Region, Manila, 1998, available from (http://www.wpro.who.int/NR/rdonlyres/24BF6429-201E-47E3-AD28-0461EDCEA193/0/Guidelines_Appropriate_Use_of_Herbal_Medicines.pdf).
6) World Health Organization, “WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants”, World Health Organization, Geneva, 2003, available from (http://libdoc.who.int/publications/2003/9241546271.pdf).
7) World Health Organization, “WHO Guidelines for Assessing Quality of Herbal Medicines with Reference to Contaminants and Residues”, World Health Organization, Geneva, 2007, available from (http://www.who.int/medicinedocs/index/assoc/s14878e/s14878e.pdf).
8) U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). “Guidance for Industry, Botanical Drug Products”, 2004, available from (http://www.fda.gov/cder/guidance/4592fnl.htm).
9) European Medicines Agency, “Guidelines on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products/Traditional Herbal Medicinal Products”, 2006, available from (http://www.emea.europa.eu/pdfs/human/qwp/282000en.pdf).
10) 厚生省薬務局監視指導課監修, 漢方GMP解説 1993年版, 薬事日報社, 東京, 1993.
11) 仲井由宣, GMP・ICH医薬用語事典, じほう, 東京, 2007.
2) The Ministry of Health, Labour and Welfare, “The Japanese Pharmacopoeia, Fifteenth Edition, English Version”, 2006, available from (http://jpdb.nihs.go.jp/jp15e/).
3) “The Japanese Standards for Herbal Medicines”, Yakuji Nippo, Tokyo, 1993.
4) World Health Organization, Regional Office for the Western Pacific, “WHO International Standard Terminologies in Traditional Medicine in the Western Pacific Region”, World Health Organization, Western Pacific Region, Manila, 2007, available from (http://www.wpro.who.int/NR/rdonlyres/14B298C6-518D-4C00-BE02-FC31EADE3791/0/WHOIST_26JUNE_FINAL.pdf).
5) World Health Organization, Regional Office for the Western Pacific, “Guidelines for the Appropriate Use of Herbal Medicines”, World Health Organization, Western Pacific Region, Manila, 1998, available from (http://www.wpro.who.int/NR/rdonlyres/24BF6429-201E-47E3-AD28-0461EDCEA193/0/Guidelines_Appropriate_Use_of_Herbal_Medicines.pdf).
6) World Health Organization, “WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants”, World Health Organization, Geneva, 2003, available from (http://libdoc.who.int/publications/2003/9241546271.pdf).
7) World Health Organization, “WHO Guidelines for Assessing Quality of Herbal Medicines with Reference to Contaminants and Residues”, World Health Organization, Geneva, 2007, available from (http://www.who.int/medicinedocs/index/assoc/s14878e/s14878e.pdf).
8) U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). “Guidance for Industry, Botanical Drug Products”, 2004, available from (http://www.fda.gov/cder/guidance/4592fnl.htm).
9) European Medicines Agency, “Guidelines on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products/Traditional Herbal Medicinal Products”, 2006, available from (http://www.emea.europa.eu/pdfs/human/qwp/282000en.pdf).
10) 厚生省薬務局監視指導課監修, 漢方GMP解説 1993年版, 薬事日報社, 東京, 1993.
11) 仲井由宣, GMP・ICH医薬用語事典, じほう, 東京, 2007.