Andrea M. Pless

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Andrea M. Pless is an associate director at Teva

Articles

Evaluating Progress in Analytical Quality by Design

Evaluating Progress in Analytical Quality by Design

Elizabeth Hewitt;Andy Rignall;Mark D. Trone;Patrick Jackson;Marion Chatfield;Mark Argentine;Qinggang Wang;Shreekant Karmarkar;Andrea M. Pless;Zeena Williams;Kimber Barnett;David Semin;Yanqun Zhao;Ariane Marolewski
April 2nd 2017

The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.

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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