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 ...
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 topics including formulation platforms, AI, amorphous solid dispersions, and ...
The scope covers prescription drugs and drug-led, drug-device combination products where the Center for Drug Evaluation and ...
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, ...
The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of ...
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to ...
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