Articles by Christopher C. DeMerlis - Pharmaceutical Technology

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Articles by Christopher C. DeMerlis

Regulatory Update: The IPEC Novel Excipient Safety Evaluation Procedure

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

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.

Clearing Regulatory Hurdles

Nov 2, 2003

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

The IPEC-Americas Excipient Master File Guide

Jun 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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