FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
News|Articles|November 15, 2016
- Pharmaceutical Technology-11-15-2016
- Volume 2016 eBook
- Issue 3
Ensuring Quality in Pharmaceutical Raw Materials
Author(s)Agnes Shanley
Ensuring that materials have optimal critical quality attributes for the required formulations is crucial.
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Gelatin is commonly used for drug encapsulation. Ensuring that materials have optimal critical quality attributes for the required formulations is crucial, as are practices that will ensure an uninterrupted supply of quality material.
Jean-Philippe Talmon, chief procurement officer at Capsugel, shares best practices, for both natural and synthetic materials.
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Articles in this issue
almost 10 years ago
Extending QMS to Contract Partnersalmost 10 years ago
Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilizationalmost 10 years ago
Investigation Effectiveness Drives Human Performance Excellencealmost 10 years ago
Is Global Regulatory Gridlock Slowing Modernization?almost 10 years ago
Paperless Batch Records for the Massesalmost 10 years ago
Could Greater Transparency Improve Pharmaceutical Quality and Compliance?almost 10 years ago
Microbiological Testing: Time is of the EssenceAdvertisement
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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.
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