Articles by David Schoneker - Pharmaceutical Technology

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Articles by David Schoneker

David Schoneker


David Schoneker is the chair-elect of the International Pharmaceutical Excipients Council of the Americas, (IPEC-Americas) and the director of global regulatory affairs at Colorcon in West Point, Pennsylvania.

Articles
An Industry Perspective on Harmonization and Implementation of ICH and USP Requirements
November 2, 2012

The US Pharmacopeia's revised General Chapters on elemental impurity limits and testing procedures are set to take effect in December 2012.

Excipient-Control Strategies
October 1, 2008

Securing the integrity of the excipient supply chain is a crucial task in ensuring the overall pharmaceutical supply chain. The authors outline excipient-control strategies and practices for the manufacture, distribution, and receipt of excipients.

Joint Position Paper on Pharmaceutical Excipient Testing and Control Strategies
September 2, 2007

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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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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