Semi-solid dosage forms are complex drug delivery systems containing one or more active ingredients dissolved or dispersed uniformly in the product. Viscosity modifiers are polymers that hydrate upon interaction with solvents and impart an increase in viscosity. It is often difficult to choose the right grade of the polymer and identify the correct amount that produces a consistent viscosity. The video presentation and research poster discuss the importance of polymer selection during formulation development.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
The Leadership Summit will bring senior pharma executives together to discuss supply chain resilience, medicine security, and manufacturing capacity amid growing geopolitical fragmentation.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.