11.28.23 -- FDA Seeks Comment On New Draft Guidance On Peptide Drug Product Pharmacology

Understand the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal.

Physiologically based pharmacokinetic modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and accelerate timelines.

As the cost of developing a biologic drug remains high, explore ways to improve your CLD process by eliminating bottlenecks in clone selection, fast-tracking timelines, and reducing costs.

Explore the application of in vitro flux assays to nanoparticles, with data on how the in vitro permeability apparatus can characterize the membrane flux performance of an API formulated as a nanosuspension.

The simultaneous spray drying of multiple ingredients is a powerful technique for making inhaled products with multiple actives. Examine how novel techniques can make these products a reality.

Explore important initial steps to consider and implement during the process design phase, which is a prerequisite to a successful PPQ campaign and readiness for commercial manufacturing.