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Drug Development and Industrial Pharmacy Volume 16, 1990 - Issue 17
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Research Article

Characterisation of Macromolecules Used as Pharmaceutical Excipients: Excipients and the Regulatory Authorities

B R Matthews Medicines Control Agency, Department of Health, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ, England
Pages 2449-2463 | Published online: 20 Oct 2008
 
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Abstract

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.

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