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|April 2, 2005
- Pharmaceutical Technology-04-02-2005
- Volume 29
- Issue 4
In the Spotlight - April 2005
Pharmaceutical Science and Technology Innovations
Articles in this issue
over 21 years ago
April 2005over 21 years ago
Management Controls for GMP Complianceover 21 years ago
PAT and Process Understanding: A Call to Armsover 21 years ago
Cold Chain Concernsover 21 years ago
Evolutions in Direct Compressionover 21 years ago
X-ray Microtomography of Solid Dosage Formsover 21 years ago
Orient ExpressRelated to this article
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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