Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|July 16, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
- PTSM: Pharmaceutical Technology Sourcing and Management-08-05-2015
- Volume 11
- Issue 8
EMA Releases API Bioequivalence Studies Guidance
Author(s)Pharmaceutical Technology Editors
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
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The European Medicines Agency (EMA) opened up for consultation product-specific guidance documents on bioequivalence studies for the active substances asenapine, prasugrel, sitagliptin, and zonisamide. The release of the guidance documents follows finalization of bioequivalence guidance on 16 active substances in 2014 and 2015.
Articles in this issue
about 11 years ago
CDMOs Move Slowly with Expansion Plansabout 11 years ago
Accelerating Continuous API Synthesisabout 11 years ago
BioOutsource Opens New Facility in Glasgowabout 11 years ago
Silicone Rubber Pieces Spur Recall of Teva Productabout 11 years ago
Baxter Recalls IV Solution for Container and Particulate Issuesabout 11 years ago
Indian API Manufacturer Cited for Recordkeeping Failuresabout 11 years ago
Xcelience Makes Investment in Powdersizeabout 11 years ago
FDA Issues Quality Metrics Draft Guidance Document for Commentabout 11 years ago
EMA Issues Guideline on Fast Tracking Drugs for Unmet NeedsAdvertisement
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