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Implementation of ICH Q3D in Product Development

pdf fileHarris L;

This presentation by Dr. Laurence. J. Harris (Lhasa Elemental Impurities consortium member and Pfizer colleague) gives a brief background on ICH Q3D before going on to consider the risk assessment process for excipients and examples using the Elemental Impurities database. This was presented at the 4th PQRI Workshop on ICH Q3D Elemental Impurities.

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