Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready ...

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, 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.

Pauric Bannigan, Intrepid Labs, explains where AI speeds formulation decisions, why data is the bottleneck, and how active learning trains models with far less data.

Stephanie Johnson, Pfizer, explains how off-platform triggers, single-owner risk registers, and traceable prior knowledge keep protein formulation programs on track. Stephanie Johnson, Pfizer, ...

Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these ...

Univar Solutions scientists developed a lidocaine cream built on starch, sorbitol, coconut oil, and beeswax that matched a commercial benchmark on viscosity, assay, and hydration.

The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.

Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 ...

Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice. Ahead ...

FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up ...

The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of ...