CHARACTERIZATION OF MACROMOLECULES USED AS PHARMACEUTICAL EXCIPIENTS - EXCIPIENTS AND THE REGULATORY AUTHORITIES

被引:0
|
作者
MATTHEWS, BR
机构
[1] Medicines Control Agency, Department of Health, Market Towers, London, SW8 5NQ, England
关键词
D O I
10.3109/03639049009058541
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
The sources of information on regulatory requirements for licensing (marketing authorisation) of pharmaceuticals in the European Community, including aspects applying to macromolecular excipients, are identified. The pharmaceutical, preclinical and clinical implications are discussed in outline. © 1990 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted.
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页码:2449 / 2463
页数:15
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