Courtney M. Callis

In silico approaches to predicting cancer potency for risk assessment of genotoxic impurities in drug substances

Joel P. Bercu, Stuart M. Morton, J. Thom Deahl et al. · Regulatory Toxicology and Pharmacology · 2010 · 38 citations

Pharmacy, Toxicology, Drug Discovery +16

Risk Assessment of Genotoxic Impurities in Marketed Compounds Administered over a Short-Term Duration: Applications to Oncology Products and Implications for Impurity Control Limits

Courtney M. Callis, Joel P. Bercu, Keith M. DeVries et al. · Organic Process Research & Development · 2010 · 28 citations

Pharmacy, Pharmacology, Toxicology +17

Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies

Patricia Parris, Elizabeth A. Martin, Brad Stanard et al. · Regulatory Toxicology and Pharmacology · 2020 · 21 citations

Pharmacy, Pharmaceutical Analysis, Pharmaceutical Regulation +8

Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls)

Melisa Masuda-Herrera, Joel P. Bercu, Thomas H. Broschard et al. · PDA Journal of Pharmaceutical Science and Technology · 2022 · 11 citations

Pharmacy, Clinical Toxicology, Toxicology +15