Complexity in the making: non-biological complex drugs (NBCDs) and the pharmacopoeias

Author(s): Professor Gerrit Borchard, PharmD, PhD

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. […]

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