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Optimizing the detection of N-nitrosamine mutagenicity in the Ames test.

Autor: Heflich RH; U.S. Food and Drug Administration, National Center for Toxicological Research, USA. Electronic address: robert.heflich@fda.hhs.gov., Bishop ME; U.S. Food and Drug Administration, National Center for Toxicological Research, USA., Mittelstaedt RA; U.S. Food and Drug Administration, National Center for Toxicological Research, USA., Yan J; U.S. Food and Drug Administration, National Center for Toxicological Research, USA., Guerrero SK; U.S. Food and Drug Administration, National Center for Toxicological Research, USA., Sims AM; U.S. Food and Drug Administration, National Center for Toxicological Research, USA., Mitchell K; U.S. Food and Drug Administration, National Center for Toxicological Research, USA., Moore N; U.S. Food and Drug Administration, National Center for Toxicological Research, USA., Li X; U.S. Food and Drug Administration, National Center for Toxicological Research, USA., Mei N; U.S. Food and Drug Administration, National Center for Toxicological Research, USA., Elespuru RK; U.S Food and Drug Administration, USA., King ST; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, USA., Keire DA; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, USA., Kruhlak NL; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Translational Sciences, USA., Dorsam RT; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, USA., Raw AS; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, USA., Davis Bruno KL; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, USA., McGovern TJ; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, USA., Atrakchi AH; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, USA.

Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 Nov; Vol. 153, pp. 105709. Date of Electronic Publication: 2024 Sep 28.

Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA).

Autor: Kruhlak NL; US Food and Drug Administration (US FDA), Silver Spring, MD, USA. Electronic address: Naomi.Kruhlak@fda.hhs.gov., Schmidt M; Danish Medicines Agency (DKMA), Copenhagen, Denmark., Froetschl R; Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany., Graber S; Swiss Agency for Therapeutic Products (Swissmedic), Bern, Switzerland., Haas B; Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany., Horne I; Therapeutic Goods Administration (TGA), Canberra, Australia., Horne S; Pharmaceutical Drugs Directorate, Health Canada, Ottawa, Ontario, Canada., King ST; US Food and Drug Administration (US FDA), Silver Spring, MD, USA., Koval IA; Medicines Evaluation Board (MEB), Utrecht, Netherlands., Kumaran G; US Food and Drug Administration (US FDA), Silver Spring, MD, USA., Langenkamp A; Swiss Agency for Therapeutic Products (Swissmedic), Bern, Switzerland., McGovern TJ; US Food and Drug Administration (US FDA), Silver Spring, MD, USA., Peryea T; US Food and Drug Administration (US FDA), Silver Spring, MD, USA., Sanh A; French National Agency for Medicines and Health Products Safety (ANSM), Saint-Denis, France., Siqueira Ferreira A; Agência Nacional de Vigilância Sanitária (ANVISA), Brasilia, Brazil., van Aerts L; Medicines Evaluation Board (MEB), Utrecht, Netherlands., Vespa A; Pharmaceutical Drugs Directorate, Health Canada, Ottawa, Ontario, Canada., Whomsley R; European Medicines Agency (EMA), Amsterdam, Netherlands.

Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 Jun; Vol. 150, pp. 105640. Date of Electronic Publication: 2024 May 14.

Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays.

Autor: Li X; National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, 72079, USA. Electronic address: xilin.li@fda.hhs.gov., Le Y; National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, 72079, USA., Seo JE; National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, 72079, USA., Guo X; National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, 72079, USA., Li Y; National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, 72079, USA., Chen S; National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, 72079, USA., Mittelstaedt RA; National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, 72079, USA., Moore N; National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, 72079, USA., Guerrero S; National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, 72079, USA., Sims A; National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, 72079, USA., King ST; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Atrakchi AH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., McGovern TJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Davis-Bruno KL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Keire DA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Elespuru RK; Discovery Life Sciences, Columbia, MD, 21045, USA., Heflich RH; National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, 72079, USA., Mei N; National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, 72079, USA. Electronic address: nan.mei@fda.hhs.gov.

Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2023 Jun; Vol. 141, pp. 105410. Date of Electronic Publication: 2023 May 18.