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|September 1, 2012
- Pharmaceutical Technology-09-01-2012
- Volume 2012 Supplement
- Issue 5
Pharmaceutical Technology CPhI Supplement, September 2012
API's, Excipients and Manufacturing
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Articles in this issue
about 14 years ago
Developing the Optimal Solid Formabout 14 years ago
Plant Focus: High-Potency Manufacturing and Sustainability at Pfizerabout 14 years ago
Achieving Process Understanding and Control in Film Coatingabout 14 years ago
Excipients in Tastemaskingabout 14 years ago
Making API Synthesis Greenerabout 14 years ago
Weighing Access and Affordabilityabout 14 years ago
Strategies for High-Containmentabout 14 years ago
The Project Management of Project Managementabout 14 years ago
Moving to Risk-Based InspectionsAdvertisement
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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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