Search results for " pharmaceutical"
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USP Stresses Pharmacopeial Standards at CPhI China
Keynote speakers included former FDA officials, USP experts, members of the Chinese Pharmacopoeia Commission, and senior pharmaceutical executives.
The seminar was designed to explain the latest q…
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Biopharma Advances Demand Specialized Expertise
…al development/manufacturing processes?
McNally (PPD Consulting): FDA established a new Office of Pharmaceutical Quality in 2014, which we anticipate will have major impacts on the biopharmaceutic…
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Ensuring the Quality of Biologicals
Wicks, “Ensuring the Quality of Biologicals,” Pharmaceutical Technology 39 (5) 2015.
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Finding Opportunities in Brazil
According to the Brazilian Pharmaceutical Trade Association (Sindusfarma), the industry does not expect 2015 to be that great overall. The sector may tend to contract with a slower job growth rate, th…
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New Era for Generic Drugs
…ined Susan Rosencrance, then acting deputy director for generic drug chemistry in CDER’s Office of Pharmaceutical Science (OPS), at the FDA/PQRI conference in September 2014. The risk-based review ap…
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DoE Provides Benefits, but Preparation Is Necessary
LaBrenz, scientific director, pharmaceutical development and manufacturing sciences with Janssen Research & Development. At the same time, DoE results depend on the selected critical parameters and th…
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Application of Quality by Design to Viral Safety
This approach uses the concepts laid out in the International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) guidelines, Q8 Pharmaceutical Development, Q9…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
The company received the 2013 Facility of the Year Award issued by the International Society for Pharmaceutical Engineering (ISPE) for its flu cell-culture technology, which it has implemented at a ne…
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
While the erosion curve will be much less steep than it is for traditional pharmaceutical products, those companies are among those that will face sales declines, Moody's reports.
But upside oppor…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
Prior to QbD, pharmaceutical development did not require the establishment of functional relationships between CPPs and CQAs. Consequently, process characterization experiments were primarily univaria…