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