Biotechnological/Biological Products: About Its Stability Testing
Keywords:
Biologicals, Stability testing, rDNA technology
Abstract
The drug delivery systems have made some of the technological advances especially in the case of biopharmaceuticals. When one talks about biotechnological product stability of drug product becomes main culprit due to dynamic nature of drug molecule. This review is grafted using ICH and other regulatory guidelines to provide an overview to stability testing of such molecules.
References
1. Quality of biotechnological products: stability testing of biotechnological/biological products q5c. Ich harmonised tripartite guideline, 1995: p. 1-7.
2. Note for guidance on quality of biotechnological products: stability testing of biotechnological/biological products. European medical agency, 1996: p. 1-9.
2. Note for guidance on quality of biotechnological products: stability testing of biotechnological/biological products. European medical agency, 1996: p. 1-9.
Published
2016-05-01
How to Cite
[1]
Chavda, V., Shaliya, D., Patel, B. and Gabani, A. 2016. Biotechnological/Biological Products: About Its Stability Testing. PharmaTutor. 4, 5 (May 2016), 14-19.
Section
Articles
