Topical Pharma: A Rheologist's Guide To Regulatory Confidence
Submitting a new drug application for a generic topical pharmaceutical requires developers to demonstrate equivalence to a reference-listed drug, which can be challenging. One of the major hurdles regulatory affairs personnel face is traversing the complex landscape of rheological measurements. Regulatory agencies like the FDA and EMA provide detailed guidelines for proving the physicochemical and structural equivalence between generic and innovator products. These guidelines demand more from formulators than basic viscometer readings; rheological properties must be generated and presented, such as viscoelastic moduli, zero-shear viscosity, yield stress, and thixotropy to fully adhere to regulatory requirements.
In this informative webinar, industry experts cover key rheology concepts and terminology and demonstrate how to generate the necessary rheological profiles using high-performance instruments. Watch to learn about selecting and developing test methods, setting up instrumentation, and analyzing and interpreting the results.
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