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Excipient Database Should Help Take Mystery Out Of ICH Q3D Risk Assessments

 
• By Joanne S. Eglovitch

The pharmaceutical industry is developing an excipient database to better enable industry to conduct risk assessments set out in the ICH Q3D guideline.

An excipient database now in existence should help manufacturers leverage existing data to assess the toxic risk posed by elemental impurities under the International Council on Harmonization Q3D guideline, said Mark Schweitzer of Novartis.

The database should be able to help the industry quantify some of the unknown risks in assessing the toxicity of elemental impurities for new and existing drug products. There are...

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