David R. Schonekerdschoneker@colorcon.com
David R. Schoneker is chairman of the International Pharmaceutical Excipients Council of the Americas. He also is director of global regulatory affairs at Colorcon. |
Inside IPEC-Americas: New Excipient Evaluation Procedure
January 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. |
Excipient Control Strategies in China
October 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. |
Excipient Control Strategies in China
September 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. |
PQRI Survey of Pharmaceutical Excipient Testing and Control Strategies Used by Excipient Manufacturers, Excipient Distributors, and Drug-Product Manufacturers
September 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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