Karen M. Alsante

Can light absorption and photostability data be used to assess the photosafety risks in patients for a new drug molecule?

Brian Henry, Christopher J. Foti, Karen M. Alsante · Journal of Photochemistry and Photobiology B Biology · 2009 · 1.9K citations

Natural Sciences, Medicinal Chemistry, Pharmacology +16

A Critical Assessment of the ICH Guideline on Photostability Testing of New Drug Substances and Products (Q1B): Recommendation for Revision

Steven W. Baertschi, Karen M. Alsante, Hanne Hjorth Tønnesen · Journal of Pharmaceutical Sciences · 2010 · 107 citations

Pharmacy, Pharmaceutical Analysis, Pharmacology +11

In Silico Prediction of Pharmaceutical Degradation Pathways: A Benchmarking Study

Mark H. Kleinman, Steven W. Baertschi, Karen M. Alsante et al. · Molecular Pharmaceutics · 2014 · 55 citations

Pharmacy, Medicinal Chemistry, Computational Chemistry +16

Pharmaceutical impurity identification: A case study using a multidisciplinary approach

Karen M. Alsante, Peter Boutros, Michel Couturier et al. · Journal of Pharmaceutical Sciences · 2004 · 50 citations

Pharmacy, Pharmaceutical Analysis, Pharmaceutics +14

Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape

Karen M. Alsante, Kim Huynh‐Ba, Steven W. Baertschi et al. · AAPS PharmSciTech · 2013 · 43 citations

Pharmacy, Pharmaceutics, Regulatory Pharmacy +17