Lipid-based formulations (LBFs) are complex mixtures of lipid, surfactant and solvent excipient, where
the composition determines the potential impact of dispersion and digestion on drug solubilization. By carefully
selecting fill formulations during the early stages of drug development, it is possible to meet the specific
requirements for bioavailability and stability for clinical trial and supply.
In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.
Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.
The FDA approves VOCERYQ, the first DNA medicine, for RRP surgery reduction, raising plasmid, drug-device, and confirmatory trial manufacturing demands.
The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
