Biotechnological/Biological Products: About Its Stability Testing

May 2016 ARTICLE LIST >>

PharmaTutor (May- 2016)

Print-ISSN: 2394 - 6679
e-ISSN: 2347 - 7881
(Volume 4, Issue 5)

Received On: 28/12/2015; Accepted On: 11/01/2016; Published On: 01/05/2016

AUTHORS:
Vivek P. Chavda^1*, Dharmesh Shaliya², Bhargav Patel³, Ashish Gabani^4
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.

How to cite this article: Chavda VP, Shaliya D, Patel B, Gaban A; Biotechnological/Biological Products: About Its Stability Testing; PharmaTutor; 2016; 4(5); 14-19

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