This document deals with the preparation of the dossier required to obtain the marketing authorization of medicaments that could be identified as generic products according to the international definition of the term. After a description of the classification of medicinal products in force in Italy, the physico-chemical, pharmacological, toxicological and clinical documents relevant to these products are analyzed from a technical point of view.
Generic products, regulatory and technical issues = Generici, aspetti regolatori e tecnici / C. Cangiano, R. Colombo, A. Gazzaniga, P. Minghetti, T. Modena, L. Montanari, P. Iamartino, C. Caramella, G. Geschel, F. De Martiis, M. Pedrani, C. Vecchio, A. Tajana, G. Coppi, S. Ferrini, V. Ravelli, A. Gazzaniga. - In: ACTA TECHNOLOGIAE ET LEGIS MEDICAMENTI. - ISSN 1121-2098. - 7:1(1996), pp. 1-29.
Generic products, regulatory and technical issues = Generici, aspetti regolatori e tecnici
A. Gazzaniga;P. Minghetti;L. Montanari;A. Gazzaniga
1996
Abstract
This document deals with the preparation of the dossier required to obtain the marketing authorization of medicaments that could be identified as generic products according to the international definition of the term. After a description of the classification of medicinal products in force in Italy, the physico-chemical, pharmacological, toxicological and clinical documents relevant to these products are analyzed from a technical point of view.
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