FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
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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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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Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.
The FDA expanded Anktiva to BCG-unresponsive papillary-only NMIBC using existing CIS trial data, a precedent with implications for development timelines and supply planning.
AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.
Boyang Wang, Immortal Dragons, discusses how the FDA’s Expedited IND Pilot must prove efficiency as sponsors chase the fastest route to valid first-in-human data.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors, CDMOs, and quality teams.
Boyang Wang, Immortal Dragons, explains how FDA’s Expedited IND Pilot and research partners could speed serial steps to first-in-human trials compared to China’s 818 Decree.
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