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Chapter 2

Regulatory Perspective on Synthetic Peptides in Europe

Synthetic peptides are of increasing importance as a class of substances used in medicinal products and the number of applications for marketing authorization has increased steadily in recent years. Based on European quality guidelines, international quality guidelines and European Pharmacopoeia (Ph. Eur.) requirements, it is discussed which data are relevant for synthetic peptides. The requirements for both marketing authorization applications and for clinical studies are addressed.

Publication details


Print publication date
28 Aug 2019
Copyright year
2019
Print ISBN
978-1-78801-433-5
PDF eISBN
978-1-78801-644-5
ePub eISBN
978-1-78801-869-2
From the book series:
Drug Discovery