In Defense of USP Singlet Testing

Robert Holt, PhD, associate director, Pharmaceutical Science, digiM Solution, discusses microstructure intelligence in more detail in part 2 of this preview of the company’s keynote presentation at AAPS PharmSci 360.

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.

On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.

This week saw predictive modeling, microstructure intelligence, a CAR T-cell safety pause, and major licensing deals reshape pharma manufacturing.

The FDA approves zilganersen, the first disease-modifying Alexander disease therapy, offering rare disease developers a trial design and RNA delivery model.

The finalists for the 2026 CPHI Pharma Awards span 15 categories including API development, digital transformation, manufacturing, supply chain, sustainability, and leadership, with winners revealed October 6 at CPHI Milan.

In part 1 of this 2-part preview of AAPS PharmSci 360’s keynote on predictive drug development, Robert Holt, PhD, associate director, Pharmaceutical Science, digiM Solution, explains microstructure intelligence and how it can enhance how drug developers understand the dosage form.

Christy Owings, Thermo Fisher, explains clinical trial supply chain risks in Latin America, importer-of-record strategy, AI, and eCOA delays.