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Chemical Research in Toxicology|December 19, 2006
A regulatory perspective on issues and approaches in characterizing human metabolitesKaren L Davis-Bruno, Aisar AtrakchiJournal of Pharmacological and Toxicological Methods|June 18, 2005
Challenges and lessons learned since implementation of the safety pharmacology guidance ICH S7AJean-Pierre Valentin, Alan S Bass, Aisar Atrakchi, et al.Mutation Research. Genetic Toxicology and Environmental Mutagenesis|August 29, 2021
Appropriate in vivo follow-up assays to an in vitro bacterial reverse mutation (Ames) test positive investigational drug candidate (active pharmaceutical ingredient), drug-related metabolite, or drug-related impurityTimothy W Robison, Robert H Heflich, Mugimane G Manjanatha, et al.The Journal of Clinical Psychiatry|May 12, 2017
The US Food and Drug Administration's Perspective on the New Antipsychotic PimavanserinMitchell V Mathis, Brendan M Muoio, Paul Andreason, et al.American Journal of Therapeutics|May 11, 2004
Regulatory toxicology perspectives on the development of botanical drug products in the United StatesKuei-Meng Wu, James Farrelly, Debra Birnkrant, et al.Mutagenesis|February 14, 2026
Nitrosamine Ames Data Review and Method Development: Proceedings of a US FDA/HESI WorkshopAisar Atrakchi, Raechel Puglisi, Joel Bercu, et al.Regulatory Toxicology and Pharmacology : RTP|May 1, 2025
HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditionsJoel Bercu, Alejandra Trejo-Martin, Connie Chen, et al.Pageof 1