Summary
For any generic pharmaceutical developer submitting a new drug application, the process of demonstrating the equivalence of a topical pharmaceutical to a reference listed drug can be a grueling process. Not least of the challenges facing regulatory affairs personnel is navigating the often-daunting landscape of rheological measurements. Agencies such as the FDA and EMA publish guidelines for demonstrating physicochemical and structural equivalence of innovator and generic products that request far more than basic viscometer measurements of old. Today’s formulators must generate and present rheological properties including viscoelastic moduli, zero-shear viscosity, yield stress and thixotropy to comprehensively meet regulatory demands.
In this accessible webinar, Josh and Alex will walk you through the rheology landscape, explaining the terminology and core concepts and showing examples of how the required rheology profiles can be generated on high performance rheometers such as TA Instrument’s Discovery Hybrid Rheometer range. Test method selection and development, instrument set up and subsequent results analysis and interpretation will be covered.
Speaker
Sales Team Lead
Centre for Industrial Rheology
Alex started at The Centre as a Technical Sales Specialist in 2017. Responsible for global sales to the Pharmaceutical, Personal Care, and Household industries, Alex has a keen eye for identifying promising techniques and valuable insights to help some of the world’s leading companies. In his current role as Sales Team Lead, he also provides training and guidance to the wider sales team to enable them to quickly pick up the fundamentals and benefits of liquid rheology, powder rheology, and interfacial rheology.
Technical Manager
Centre for Industrial Rheology
Joshua obtained his bachelor’s degree in chemistry from the University of Bristol and joined the Centre for Industrial Rheology in 2015 working in the analytical team, moving into the role of Technical Manager in 2019. In this role he oversees the testing performed at the centre, guiding the analysis of materials from across the breadth of industries the centre assists. Josh also provides training courses and consulting support, through which he helps companies of all sizes make the most of their rheological capabilities, ensuring they fully comprehend, and can effectively exploit, the insights delivered.
