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 animal studies.
|Articles|July 1, 2001
- Pharmaceutical Technology-07-02-2001
- Volume 25
- Issue 7
Statistical Thinking
An important advancement in statistics may be a new approach to implementing statistical thinking into industry processes.
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Articles in this issue
over 25 years ago
Musings on the Past 25 Yearsover 25 years ago
Reflections on Changes at FDAover 25 years ago
Deliver the Doseover 25 years ago
Middle-European Pharmaceutics in a Changing Worldover 25 years ago
The BCS: Where Do We Go From Here?over 25 years ago
From Inactive Ingredients to Pharmaceutical Excipientsover 25 years ago
Am I Going Backwards?over 25 years ago
The Filter Scene: Old and Newover 25 years ago
Catching Up with Expert SystemsAdvertisement
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Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
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