Regulatory guidelines and key aspects of guidelines in the use of biologics

Author: 
Lakshmi Prabha J and Uma Maheswari T.N

Biologics are used in the treatment of immune mediated disease aimed a modulating lymphocytes or cytokines. They can be categorized broadly into three categories: TNF-α inhibitors, lymphocyte modulators and interleukin inhibitors. Regulatory guidelines for the development of biologics include validations of various steps in development, standard guidelines, manufacturing guidelines, analytical tests. Hence, in this article the regulatory guidelines and key aspects of guidelines in the use of biologics in oral medicine are presented.

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DOI: 
http://dx.doi.org/10.24327/ijcar.2017.3269.0242