Articles by Dale Carter - Pharmaceutical Technology

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Articles by Dale Carter

Standardized Excipient GMP

This article provides guidance for industry on how to comply with the pending American National Standard on excipient GMP, with a focus on risk assessment. This article is part of a special issue on solid dosage and excipients.
Mar 1, 2012

This article provides guidance for industry on how to comply with the pending American National Standard on excipient GMP, with a focus on risk assessment.

Risk Assessment for Excipients for Enhanced Patient Safety

The author describes key considertions for a complete risk-assessment model and provides insight into a pending IPEC guideline in this area.
Apr 1, 2011

The author describes key considertions for a complete risk-assessment model and provides insight into a pending IPEC guideline in this area.

Joint Position Paper on Pharmaceutical Excipient Testing and Control Strategies

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.
Sep 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?
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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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