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, 2016
- Pharmaceutical Technology-09-01-2016
- Volume 2016 Supplement
- Issue 3
Pharmaceutical Technology, 2016 APIs, Excipients, and Manufacturing Supplement (PDF)
Click the title above to open the Pharmaceutical Technology 2016 APIs, Excipients, and Manufacturing Supplement in an interactive PDF format.
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Articles in this issue
about 10 years ago
Determining Minimum Batch Sizeabout 10 years ago
Optimizing API Manufacturingabout 10 years ago
Dealing With Complexity in Excipients and Formulationsabout 10 years ago
A Novel Solid-Dose Injectionabout 10 years ago
Data Integrity Emerges as an Excipients Issueabout 10 years ago
Contract Service Providers Tackle Biopharma Challengesabout 10 years ago
Topical Formulation: Moving From Art to ScienceAdvertisement
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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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