M. McMahon

Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies

Robert J. Timpano, Elke Debie, Y. Babayan, 2021, The AAPS Journal.

Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities

Timothy J. N. Watson, J. Berridge, S. M. Tyler, 2018, Journal of Pharmaceutical Innovation.

Utilization of risk-based predictive stability within regulatory submissions; industry’s experience

Yan Wu, Jin Wang, Helen Williams, 2020 .