Theresa Natishan

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Theresa Natishan is a director at Merck

Articles

Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach

Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach

Frank Diana;Jeff Hofer;Marion Chatfield;Nancy Benz;Yuan Huang;Mark Argentine;Qinggang Wang;Shreekant Karmarkar;Hafez Abdel-Kader;Lakshmy M. Nair;Hui Fang;Theresa Natishan;Andrea M. Pless;Rick Burdick;Zeena Williams

October 2nd 2014

A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.

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