European Pharmacopoeia (Ph. Eur.) monographs for biologicals have existed since the 1990s and remain the publicly available standard defining the quality of these medicines. Continued development of such monographs, however, faces considerable challenges and the value and utility of these monographs have been questioned in recent years. What such challenges are and how they can be overcome is discussed by Head of Division of the European Pharmacopoeia Department at the EDQM, Dr Emmanuelle Charton, in a GaBI Journal paper [1].
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Genéricos
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