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How Zeneth fits into ICH Q3D

pdf fileBurns MJ;

Presented by Dr Michael Burns at the 2018 Pharmaceutical Industry and Regulators Symposium held in Brazil.

This presentation discusses the applicability of Zeneth to the ICH Q3B guidelines and compares it to that of the RDC 53/2015 guidelines. A summary of the Zeneth methodology is also given as well as a proposed workflow for how Zeneth could be used in a degradant assessment.

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