Articles by Christopher C. DeMerlis - Pharmaceutical Technology

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Articles by Christopher C. DeMerlis

Christopher C. DeMerlis

regulatory affairs manager

www.colorcon.com

Christopher C. DeMerlis is a regulatory affairs manager at Colorcon, a division of Berwind Pharmaceutical Services, Inc., 415 Moyer Blvd., West Point, PA 19486, tel. 215.661.2766, fax 215.661.2778.

Articles
Regulatory Update: The IPEC Novel Excipient Safety Evaluation Procedure
November 2, 2009

The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.

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.

Clearing Regulatory Hurdles
November 2, 2003

The authors propose several models for independent evaluation of new excipients.

The IPEC-Americas Excipient Master File Guide
June 1, 2002

A global drug master file system may pave the way for faster qualifications of new excipients and the industry's acceptance of their use in drug therapies.

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