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.
News|Articles|September 2, 2004
- Pharmaceutical Technology-09-02-2004
- Volume 28
- Issue 9
Use of the Bergum Method and MS Excel to Determine the Probability of Passing the USP Content Uniformity Test
Author(s)Pramote Cholayudth
A straightforward approach reveals how the probability of passing the USP content uniformity test can be calculated for tablets and capsules.
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Articles in this issue
about 22 years ago
In the Spotlight-September 2004about 22 years ago
Promoting Quality in Drug Manufacturingabout 22 years ago
Automation in a Digital, Webbed, and Wireless Ageabout 22 years ago
September 2004about 22 years ago
Design of an Aseptic Process Simulationabout 22 years ago
Early Development Still Driving CRO Performanceabout 22 years ago
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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.
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.
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.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
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