Ensuring Compliance for Pharma Companies Through Local Label Deviations

The modern trial strategies of today accommodate for a more modern, patient-focused approaches inclusive of the needs of sites and patients.

Hot Melt Extrusion (HME) is an established processing technology that can be used for the development of paediatric formulations. The processing of lipids via HME has been proved ideal for high drug loaded dosage forms with sustained release of drugs. The study investigates the effect of the lipid type and the food grade on the dissolution rates of extruded pellets or extemporaneous formulations.

What does the future of your drug discovery program look like? Many industry leaders are finding themselves in uncharted waters: the science is more sophisticated than ever, producing paradigm-altering treatments. But, historically high R&D costs and low success rates has emphasized the need to identify drugs focused on translationally-relevant targets in the most cost and time efficient way.

Heritable disorders can often be linked back to a specific gene or genetic variant which transmits the risk of disease across generations. In most cases, the penetrance, or risk of being affected by the disease, for a pathogenic variant carrier is less than 100%. For an increasing number of disorders, the penetrance is even lower (20-50%), which begins to confound our ability to understand the relationship between disease risk and a specific genetic variant. At this level, classical tools, including family and functional studies, for assessment of variant pathogenicity loose power. This webinar will address the utility of the different lines of evidence in the classification of variants in moderate penetrance disease and recommended modifications to multivariate analysis in this setting.