Articles by David R. Schoneker - Pharmaceutical Technology

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Articles by David R. Schoneker

Conforming to the IPEC CoA Guide

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

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

IPEC extends its reach to Brazil and Argentina in an effort to harmonize excipient best practices.
Dec 2, 2010

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

Inside IPEC: New Excipient Evaluation Procedure

Pharmaceutical manufacturers often avoid putting new excipients in their formulations for fear of more regulatory oversight. IPEC has a solution.
Jan 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

As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.
Oct 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

As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.
Sep 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

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

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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