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European Regulatory Perspective on Super-Generics: Antacid Orally Disintegrating Tablets (ODT)By Achin jain, Mudit Dixit, Vasant Samaga, B. G. Bairy, Rohit Dixit, M. P. Venkatesh
Abstract: Super-generic is the general form of nomenclature for hybrid medicinal product in European Union (EU). The super-generic form of the medicinal product is one that considers changes in the form of active substance, therapeutic indications, strength, pharmaceutical form or route of administration. They rely partly on results of preclinical tests and clinical trials of an innovator product and also on new data with appropriate bioavailability and bioequivalence studies. Marketing authorization …
Published in Trends in Drug Delivery · Vol. 3, Issue 1, 2016 · pp. 31–37 Read article →