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KMID : 1011520080030010041
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Regulatory Research on Food, Durg and Cosmetic
2008 Volume.3 No. 1 p.41 ~ p.47
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Informations on Safety, LD50 and Regulation Status from Handbook of Pharmaceutical Excipients
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Cho Cheong-Weon
Park Hyo-Min
Park In-Sook
Jung Joo-Yeon
Chung Sang-Jeon
Lee Sun-Hee
Hwang Sung-Joo
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Abstract
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It is a principle that pharmaceutical additives should be safe, nontoxic and inactive when it was used with active ingredients, therefore, the safety and LD50 might be the criteria point for the selection of pharmaceutical additives. However, there was no report to show the safety of pharmaceutical additives up to date. This report was to summarize the safety and LD50 based on the text of “Handbook of Pharmaceutical Excipients” and to database for researcher to select pharmaceutical additives, practically. Also, references corresponding the issue of pharmaceutical additives were labelled and the researchers could find the detail information by search. As well as, this work summarized the regulatory status of pharmaceutical additives in foreign.
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KEYWORD
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Pharmaceutical Additives, safety, LD50, Regulatory Status
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