BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS: ABOUT ITS STABILITY TESTING
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ABOUT AUTHORS
Vivek P. Chavda1*, Dharmesh Shaliya2, Bhargav Patel3, Ashish Gabani4
1Department of Pharmaceutics, B.K. Mody Government Pharmacy College, Rajkot, Gujarat, India
2Quality Assurance, Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India
3Quality Assurance, Zydus cadila pharmaceuticals Ltd., Ahmedabad, Gujarat, India
4 Intas Biopharmaceuticals Ltd., Ahmedabad, Gujarat, India
* vivek7chavda@gmail.com
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.
