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  • Title: International specification setting--EP perspectives. European Pharmacopoeia.
    Author: Calam DH.
    Journal: Dev Biol (Basel); 2002; 107():129-34. PubMed ID: 12079187.
    Abstract:
    The regulatory framework for medicines in Europe is outlined and the role and policies of the European Pharmacopoeia in setting requirements for biotechnology products are discussed.
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