Session by Dr Sachin Dhondiram Patil, Associate VP, AR&D, Caplin Steriles

In this video:
Session by Dr Sachin Dhondiram Patil, Associate VP, AR&D, Caplin Steriles

Topic: Analytical strategies for complex therapeutics

Key Highlights:
+ CMC issues in analytical methodologies include lack of standardised analytical methodologies for characterisation of complex products

+ Requirements of FDA in product-specific guidelines are very extensive. It is important to meet those requirements before submitting the dossier

+ Novel, more discriminative methodologies developed by the industry are not accepted by the agency since they don’t match USP

+ Analytical method development for complex formulations should consider sample viscosity, sample dilution, particle refractive index and sample temperature