Quality specifications for peptide drugs: a regulatory-pharmaceutical approach

Author:

Vergote Valentijn,Burvenich Christian,Van de Wiele Christophe,De Spiegeleer Bart

Publisher

Wiley

Subject

Organic Chemistry,Drug Discovery,Pharmacology,Molecular Biology,Molecular Medicine,General Medicine,Biochemistry,Structural Biology

Reference65 articles.

1. European Pharmacopoeia, 6th edn + Supplements 6.1 to 6.5. European Directorate for the Quality of Medicines & HealthCare: Strassbourg, France, 2008-2009.

2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): Geneva, Switzerland; http://www.ich.org/cache/compo/276-254-1.html [Last accessed June 2009].

3. Proceedings of the International Symposium ‘New Impurities Control: Setting Specifications for Antibiotics and Synthetic Peptides’, 21-22 September 2006. European Directorate for the Quality of Medicines & HealthCare (EDQM): Strassbourg, France. http://www.edqm.eu/medias/fichiers/proceedings_impurities_control.pdf [Last accessed June 2009].

4. Peptide synthesis: chemical or enzymatic;Guzman;Electron. J. Biotechnol.,2007

5. United States Pharmacopeia, USP 32/NF 27. The United States Pharmacopeial Convention: Rockville, MD, 2009.

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