Article ID Journal Published Year Pages File Type
2500242 Farmacia Hospitalaria 2010 6 Pages PDF
Abstract
Authorisation according to the EMEA guidelines for biosimilars by centralized approval procedure, to demonstrate quality, efficacy and safety compared to the reference product Neupogen®. Comprehensive phase I and phase III clinical studies involving 880 subjects and patients have been completed (table 1).
Related Topics
Health Sciences Pharmacology, Toxicology and Pharmaceutical Science Pharmaceutical Science
Authors
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