Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.
|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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The FDA approves VOCERYQ, the first DNA medicine, for RRP surgery reduction, raising plasmid, drug-device, and confirmatory trial manufacturing demands.
Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.
Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.
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.
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.
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