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Ann Pharm Fr ; 61(5): 295-9, 2003.
Artigo em Francês | MEDLINE | ID: mdl-13130286

RESUMO

When it specifies the medicinal product, the article L.5111-2 of Code de la santé publique refers first of all to its "special packaging". The packaging, integral part of the medicinal product, does not only ensure its identification, it takes a decisive participation in maintaining drug quality and integrity; and moreover it facilitates its administration, therefore its good use, as well as its therapeutic observance. During the future drug development, the packaging is going to change, according to the development's phases, to lead to the final presentation which will be precisely described in the marketing authorization application. The packaging "cahier des charges" must be developed very early in order to guarantee drug quality and if needed, functionality of the device during storage. So it is a key element of drug preservation, which must be compatible with the market distribution. The pharmacist has to his disposal many kinds of material which can be used: glass, various plastic materials, aluminium, alumino-plastic complex, elastomers. Some examples highlight the industrial, security, prescription and administration aspects which must be taken into consideration during the development of a medicinal product in order to obtain the marketing authorization application, then to ensure permanence of drug qualities during its marketing.


Assuntos
Embalagem de Medicamentos/normas , Indústria Farmacêutica , Embalagem de Medicamentos/legislação & jurisprudência , Embalagem de Medicamentos/tendências , França , Preparações Farmacêuticas/normas
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