This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|March 15, 2016
- Pharmaceutical Technology-03-15-2016
- Volume 2016 eBook
- Issue 1
Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug Substances
The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.
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The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.
from Pharmaceutical Technology’s 2016 Solid Dosage Drug Development and Manufacturing eBook.
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over 10 years ago
Optimizing Tablet Compressionover 10 years ago
Excipient Quality and Selectionover 10 years ago
Filling the Analysis Gap in the Move to Continuous Processingover 10 years ago
Modeling and Simulation Move Downstreamover 10 years ago
Unifying Excipient Databasesover 10 years ago
Establishing a New Performance Standard for HPMC CapsulesAdvertisement
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