Filtered By:
Specialty: Biomedical Science
Management: Marketing
This page shows you your search results in order of date.
Order by Relevance | Date
Total 79 results found since Jan 2013.
Live biotherapeutic products and their regulatory framework in Italy and Europe
Ann Ist Super Sanita. 2023 Jan-Mar;59(1):56-67. doi: 10.4415/ANN_23_01_09.ABSTRACTIn Italy and Europe, live microorganisms-containing products meant to be used by vulnerable or sick people for preventing or curing a disease are defined as live biotherapeutic products and are regulated as biological drugs. As such, they must undergo extensive quality, safety and efficacy testing and evaluation before receiving a marketing authorization. This review describes the regulatory framework of live biotherapeutic products with special focus on the European Pharmacopoeia monograph 3053 that set mandatory requirements for this kind o...
Source: Ann Ist Super Sanita - March 28, 2023 Category: Biomedical Science Authors: Giovanna Franciosa Serena Guida Maria Jesus Gomez Miguel Christina Von Hunolstein Source Type: research
