Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready ...
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.
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 ...
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 ...
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, ...
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to ...
The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of ...
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go ...
Bill Williams, AAPS, compares KinetiSol and spray drying for amorphous solid dispersions, covering 75% drug loading, pill ...
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it ...
PharmTech spoke with Pauric Bannigan, chief scientific officer and co-founder, Intrepid Labs, at AAPS PharmSci 360 2026, ...
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