Development of quality specifications for peptide drugs
Bart M. J. De Spiegeleer, Valentijn Vergote, Christian Burvenich · Ghent University Academic Bibliography (Ghent University) · 2008
Peptides show great pharmaceutical potential as active drugs in different therapeutic areas like allergy, anti-infection, oncology, obesity, etc and as functional excipients in drug delivery systems to overcome tissue and cellular membrane barriers.The development of a peptide toward a pharmaceutical compound poses however unique challenges: the rational development of its quality specifications is one of the major issues in this process.We present here the current regulatory quality status for peptide drugs.Differences and similarities in guidelines and pharmacopoeial differences will be highlighted, leading to a proposal of a consistent basic monograph.