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|January 2, 2010
- Pharmaceutical Technology-01-02-2010
- Volume 34
- Issue 1
Pharmaceutical Technology North America, January 2010 (PDF)
Quality by Design, Deficiencies in Generic Drug Applications, API Growth, Topical Berberine-Hydrochloride Products
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Articles in this issue
almost 17 years ago
Understanding Biological Indicator Grow-Out Timesalmost 17 years ago
The Formulation and Evaluation of Topical Berberine-Hydrochloride Productsalmost 17 years ago
Healthcare Reform Requires Room for Innovationalmost 17 years ago
Pharma Faces Multiple Challenges in the Year Aheadalmost 17 years ago
A Look Ahead for 2010almost 17 years ago
In the Field: Report from Brazilalmost 17 years ago
GSK Gets under Your Skinalmost 17 years ago
Tracking API Growthalmost 17 years ago
Statistical Solutions: %RSD: Friend or Foe?Advertisement
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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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