Past IPEC-Americas excipient qualification committee chairs highlight changes to the IPEC guide on certificates of analysis for bulk excipients.
Mar 2, 2013
By:
Juanita Garofolo, David Klug, David R. Schoneker
Past IPEC-Americas excipient qualification committee chairs highlight changes to the IPEC guide on certificates of analysis for bulk excipients.
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The author focuses on how industry can build a system for Total Excipient Control.
Apr 1, 2011
By:
David R. Schoneker
The author focuses on how industry can build a system for Total Excipient Control.
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IPEC extends its reach to Brazil and Argentina in an effort to harmonize excipient best practices.
Dec 2, 2010
By:
David R. Schoneker
IPEC extends its reach to Brazil and Argentina in an effort to harmonize excipient best practices.
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Pharmaceutical manufacturers often avoid putting new excipients in their formulations for fear of more regulatory oversight. IPEC has a solution.
Jan 2, 2008
By:
Christopher C. DeMerlis, Jay M. Goldring, David R. Schoneker
Pharmaceutical manufacturers often avoid putting new excipients in their formulations for fear of more regulatory oversight. IPEC has a solution.
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As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.
Oct 4, 2007
By:
David R. Schoneker
As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.
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As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.
Sep 1, 2007
By:
David R. Schoneker
As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.
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The results from a Product Quality Research Institute study provide insights about the decisions of excipient manufacturers and drug-product manufacturers regarding testing excipient quality and using excipients in pharmaceutical manufacturing.
Sep 2, 2006
By:
Gregory Larner, David R. Schoneker, Catherine Sheehan, Rajendra Uppoor, Phyllis Walsh, Robert Wiens
The Product Quality Research Institute (PQRI) conducted an open, publicly available, electronic survey of current excipient-control strategies among pharmaceutical excipient manufacturers, excipient distributors, and drug-product manufacturers (excipient users). Among the major findings are:
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