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Drug Discovery
Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing and Controls
Edited by
Ved Srivastava
Ved Srivastava
Global Peptide Science Institute (GPSi), USA
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Hardback ISBN:
978-1-78801-433-5
PDF ISBN:
978-1-78801-644-5
EPUB ISBN:
978-1-78801-869-2
Special Collection:
2019 ebook collection
Series:
Drug Discovery
No. of Pages:
543
Published online:
16 Aug 2019
Published in print:
28 Aug 2019
Book Chapter
Chapter 2: Regulatory Perspective on Synthetic Peptides in Europe
By
René Thürmer
René Thürmer
BfArM, Federal Institute for Drugs and Medical Devices
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Germany
[email protected]
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Published:16 Aug 2019
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Special Collection: 2019 ebook collectionSeries: Drug Discovery
Page range:
31 - 68
Citation
R. Thürmer, in Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing and Controls, ed. V. Srivastava, The Royal Society of Chemistry, 2019, ch. 2, pp. 31-68.
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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.
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