ICH Q5C Stability Testing of Biotechnological/Biological Products
Author:
Affiliation:
1. MedImmune; Gaithersburg MD USA
2. AstraZeneca; Frederick MD USA
3. Current Affiliation: GlaxoSmithKline; Rockville MD USA
Publisher
John Wiley & Sons, Inc.
Reference43 articles.
1. ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products 1996
2. ICH Q1A(R2): Stability Testing of New Drug Substances and Products 2003
3. Stability of protein pharmaceuticals: an update;Manning;Pharm Res,2010
4. ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process 2004
5. Vaccine instability in the cold chain: mechanisms, analysis and formulation strategies;Kumru;Biologicals,2014
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