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    Lhasa Limited
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    JUN 2016
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Elemental impurities in excipients: a pre-competitive data sharing initiative to support risk assessment under ICH Q3D.

pdf fileHeghes C;

This poster was presented by Crina Heghes at the JPAG Meeting 2016. 


ICH Q3D establishes permitted daily exposures (PDEs) for elemental impurities of toxicological concern in drug products. Excipients represent one potential source of such impurities. Our goal was to develop a framework for pre-competitive sharing of analytical data relating to excipient elemental impurity levels to support the use of such data in risk assessment under ICH Q3D. 


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