Articles by David R. Schoneker - Pharmaceutical Technology

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Articles by David R. Schoneker

David R. Schoneker


David R. Schoneker is chairman of the International Pharmaceutical Excipients Council of the Americas. He also is director of global regulatory affairs at Colorcon.

Articles
Conforming to the IPEC CoA Guide
March 2, 2013

Past IPEC-Americas excipient qualification committee chairs highlight changes to the IPEC guide on certificates of analysis for bulk excipients.

Total Excipient Control: A Pathway to Increased Patient Safety
April 1, 2011

The author focuses on how industry can build a system for Total Excipient Control.

Inside IPEC: Global Initiatives to Expand to Latin America
December 2, 2010

IPEC extends its reach to Brazil and Argentina in an effort to harmonize excipient best practices.

Inside IPEC: New Excipient Evaluation Procedure
January 2, 2008

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

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

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

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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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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