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Regulatory Toxicology and Pharmacology : RTP|May 3, 2017
Calculation of a permitted daily exposure value for the solvent 2-methyltetrahydrofuranPatricia Parris, J Neil Duncan, Andrew Fleetwood, et al.International Journal of Toxicology|February 2, 2021
Deriving Compound-Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis: Challenges in Expert Decision-Making Exemplified Through a Case Study-Based WorkshopWilliam C Drewe, Krista L Dobo, Zhanna Sobol, et al.PDA Journal of Pharmaceutical Science and Technology|June 28, 2024
Characterizing Extractables and Leachables Chemical Space to Support In Silico Toxicological Hazard AssessmentsCandice Johnson, Arianna Bassan, Doug Kiehl, et al.Journal of Pharmaceutical Sciences|January 4, 2024
Cell and Gene Therapies: Challenges in Designing Extractables and Leachables Studies and Conducting Safety AssessmentsAdeyma Arroyo, Petra Booij, Getachew Woldemariam, et al.Regulatory Toxicology and Pharmacology : RTP|June 9, 2026
Exploring the Chemical Space of Pharmaceutical Extractables and LeachablesLidiya Stavitskaya, Arianna Bassan, R Daniel Mellon, et al.Regulatory Toxicology and Pharmacology : RTP|September 2, 2023
Assessing the utility of common arguments used in expert review of in silico predictions as part of ICH M7 assessmentsAlex N Cayley, Robert S Foster, Alessandro Brigo, et al.Regulatory Toxicology and Pharmacology : RTP|September 25, 2023
Harmonisation of read-across methodology for drug substance extractables and leachables (E&Ls)Melisa Masuda-Herrera, Hannah T Rosen, Anders Burild, et al.Chemical Research in Toxicology|February 25, 2022
Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N-Nitrosamine ImpuritiesKrista L Dobo, Michelle O Kenyon, Olivier Dirat, et al.Regulatory Toxicology and Pharmacology : RTP|August 7, 2021
Calculating qualified non-mutagenic impurity levels: Harmonization of approachesJessica C Graham, Mark W Powley, Erika Udovic, et al.Critical Reviews in Toxicology|June 15, 2022
Framework for sensitization assessment of extractables and leachables in pharmaceuticalsPatricia Parris, Geraldine Whelan, Anders Burild, et al.Pageof 2