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Communications Medicine|May 17, 2025
Regulating the AI-enabled ecosystem for human therapeuticsRominder Singh, Mark Paxton, Jared AuclairFrontiers in Medicine|November 3, 2025
Reimagining drug regulation in the age of AI: a framework for the AI-enabled Ecosystem for TherapeuticsRominder Singh, Karen Zhou, Jared R AuclairTherapeutic Innovation & Regulatory Science|May 12, 2024
Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 GuidelinesRominder Singh, William Wang, Aloka Chakravarty, et al.Pharmaceutics|March 28, 2026
Artificial Intelligence and the Transformation of Cell and Gene Therapy DevelopmentJared R Auclair, Jeewon Joung, Maya A Singh, et al.Frontiers in Drug Safety and Regulation|March 25, 2026
Federating AI-related regulations for human therapeutics: an AI-enabled, continuously updating regulatory intelligence systemRominder Singh, Mukesh Pareek, Michael Prokle, et al.Journal of Pharmaceutical and Biomedical Analysis|July 19, 2005
In vitro metabolism of a thrombin inhibitor and quantitation of metabolically generated cyanideC Charles Lin, Bradley K Wong, Christopher S Burgey, et al.JCO Clinical Cancer Informatics|September 30, 2024
Informatics and Artificial Intelligence-Guided Assessment of the Regulatory and Translational Research Landscape of First-in-Class Oncology Drugs in the United States, 2018-2022Jay G Ronquillo, Brett South, Prakash Naik, et al.Drug Metabolism and Disposition: the Biological Fate of Chemicals|October 23, 2003
Bioactivation of the 3-amino-6-chloropyrazinone ring in a thrombin inhibitor leads to novel dihydro-imidazole and imidazolidine derivatives: structures and mechanism using 13C-labels, mass spectrometry, and NMRRaju Subramanian, Charles C Lin, Jonathan Z Ho, et al.Chemical Research in Toxicology|February 18, 2003
Metabolic activation of a pyrazinone-containing thrombin inhibitor. Evidence for novel biotransformation involving pyrazinone ring oxidation, rearrangement, and covalent binding to proteinsRominder Singh, Maria V Silva Elipe, Paul G Pearson, et al.Drug Metabolism and Disposition: the Biological Fate of Chemicals|April 19, 2005
Induction of CYP1A in the beagle dog by an inhibitor of kinase insert domain-containing receptor: differential effects in vitro and in vivo on mRNA and functional activityChristopher R Gibson, Charles Lin, Rominder Singh, et al.Pageof 2