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|February 2, 2012
- Pharmaceutical Technology-02-02-2012
- Volume 36
- Issue 2
Pharmaceutical Technology, February 2012 Issue (PDF)
Applying QbD Principles to Drug Substance Development and Manufacture : Inside ICHQ11
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Articles in this issue
over 14 years ago
FDA and Justice Department Address Drug Quality Concernsover 14 years ago
Sustainable Investmentover 14 years ago
Shipping with the Enemy?over 14 years ago
FDA's Social Media Insightover 14 years ago
Expanding Capabilities in the Pharmaceutical Cold Chainover 14 years ago
Evaluating Impurities in Drugs (Part I of III)over 14 years ago
Reducing Common Cause Variationover 14 years ago
Biomanufacturing Outlookover 14 years ago
Formulation Development Forum: Boronate Cross-linked Micellesover 14 years ago
Saving the Next Generation of Regulatory ScientistsAdvertisement
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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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