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ICH Q3D: Practical implementation and the role of excipient data in a risk based approach

Teasdale A;

Presented as part of the 2016 vICGM series by Dr. Andrew Teasdale, AstraZeneca.

ICH Q3D advocates the use of a risk based approach to the assessment of the risk posed by elemental impurities. A major challenge in adopting such an approach is in balancing the need to generate data through testing against the potential use of existing knowledge. This talk will look to examine this…




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