Session by Shitalkumar Pathak, VP – Analytical Research (Formulations), Glenmark Pharmaceuticals

In this video:
Session by Shitalkumar Pathak, VP – Analytical Research (Formulations), Glenmark Pharmaceuticals

Topic: Optimising analytical functions for accelerated drug development

Key Highlights:
+ ANDA product development process involves API development and research, formulation development and research, analytical research and development & regulation, among others

+ One must be a partner in development rather than a supporter/service provider, and use scientific acumen to fast track the activities over popular shortcuts

+ There are 4 pillars of analytical development: human resource, instrumentation, analytical procedures and material selection

+ The overall role in analytical research involves method development, process optimisation, stability studies, etc

+ One should be aware of the situation, facilities, training levels, etc; as, by knowing these things, a suitable analytical development method can be created

+ It is important for analytical scientists to have the knowledge about the regulatory requirements