This article presents collaborative positions among excipient manufacturers, drug product manufacturers, and members of the US Pharmacopeia on key issues pertaining to the control of pharmaceutical excipients stemming from a recent Pharmaceutical Quality Research Institute workshop.
Sep 2, 2007
By:
Brian Carlin, Dale Carter, Moira Griffiths, Gregory Larner, Kevin Moore, Barry Rothman, David Schoneker, Catherine Sheehan, Rajendra Uppoor, Phyllis Walsh, Robert Wiens
This article presents collaborative positions among excipient manufacturers, drug product manufacturers, and members of the US Pharmacopeia on key issues pertaining to the control of pharmaceutical excipients stemming from a recent Pharmaceutical Quality Research Institute workshop.
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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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