Consortium Grows As Drugmakers Share Excipient Metal Impurities Data To Ease ICH Q3D Testing Burden
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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The pharmaceutical industry is developing an excipient database to better enable industry to conduct risk assessments set out in the ICH Q3D guideline.
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