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Consortium Grows As Drugmakers Share Excipient Metal Impurities Data To Ease ICH Q3D Testing Burden

 
• By Joanne S. Eglovitch

More manufacturers are contributing their analytical data to an excipient database to pool knowledge on the risk posed by excipients that may cause drugs to exceed acceptable PDE levels under ICH Q3D.

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More Manufacturers Signing Up To Excipient Database To Share Information • Source: Shutterstock

More manufacturers are agreeing to pool their knowledge on excipient elemental impurity risks and contribute to a centralized database to help ease risk assessments called for by the International Council on Harmonization’s Q3D guideline.

Laurence Harris, director of global GMP analytics for Pfizer Inc. gave an update, and touted the benefits, of the excipient database on 10 November at a workshop on ICH...

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