30. August 2016

Abstract Pharmacopoeias, as standard references for pharmaceutical drug specifi cations and reference standards in the form of monographs, play a pivotal role to assure drug quality and safety. With emphasis on the activities concerning non-biological complex drugs (NBCDs), the mechanisms by which new monographs are introduced into the European and the US pharmacopoeias are presented. Introduction Over the last decades we came to realize that high molecular weight drugs of biological origin,...