Výsledky vyhledávání - "Wisialowski TA"

Akademický článek

Reevaluating safety pharmacology respiratory studies within the ICH S7A core battery: A multi-company evaluation of preclinical utility and clinical translation.

Autor: Friedrichs GS; Novartis Biomedical Research, 1 Health Plaza, East Hanover, NJ 07936-1080, USA. Electronic address: greg.friedrichs@novartis.com., Abernathy MM; Eli Lilly Corporate Center, 893 Delaware St, Indianapolis, IN 46225, USA., Ackley D; Eli Lilly Corporate Center, 893 Delaware St, Indianapolis, IN 46225, USA., Clark M; Ability Biologics, 3 Place Ville-Marie Suite 400, Montréal, Québec H3B 4W8, Canada., DaSilva JK; Pfizer Research and Development, 445 Eastern Point Rd Groton, CT 06340, USA., Foley CM; Abbvie Inc, North Chicago, IL, 60064, USA., Greiter-Wilke A; Roche Innovation Center Basel, Grenzacherstr. 124, CH 4070 Basel, Switzerland., Henderson KA; Amgen Inc., Translational Safety & Bioanalytical Sciences, Thousand Oaks, CA 91320, USA., Kremer JJ; Novartis BioMedical Research, 220 Massachusetts Avenue, Cambridge, MA 02139, USA., Morimoto BH; Alto Neuroscience, Inc. 369 S San Antonio Rd, Los Altos CA 94022, USA., Paglialunga S; Celerion, 2420 W Baseline Rd, Tempe, AZ 85283, USA., Pugsley MK; Cytokinetics, 350 Oyster Point Blvd, South San Francisco, CA 94080, USA., Regan CP; Merck & Co., Inc., West Point, PA 19486, USA., Rossman EI; GSK, 1250 Collegeville Avenue, Collegeville, PA 19426, USA., Segretti JA; Abbvie Inc, North Chicago, IL, 60064, USA., Traebert M; Novartis BioMedical Research, Postfach, 4002 Basel, Switzerland., Vargas HM; Amgen Inc., Translational Safety & Bioanalytical Sciences, Thousand Oaks, CA 91320, USA., Wisialowski TA; Pfizer Research and Development, 445 Eastern Point Rd Groton, CT 06340, USA.

Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 Nov; Vol. 153, pp. 105706. Date of Electronic Publication: 2024 Sep 16.

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Akademický článek

Assessment of corrected JT-peak (JTpc) and Tpeak-to-Tend (TpTec) as proarrhythmia biomarkers in non-human primates: Outcome from a HESI consortium.

Autor: Boulay E; Charles River Laboratories, Laval, Quebec, Canada; GREPAQ (Groupe de recherche en pharmacologie animale du Québec), Université de Montréal, St-Hyacinthe, Québec, Canada., Authier S; Charles River Laboratories, Laval, Quebec, Canada; GREPAQ (Groupe de recherche en pharmacologie animale du Québec), Université de Montréal, St-Hyacinthe, Québec, Canada. Electronic address: simonauthier@hotmail.com., Bartko T; Labcorp Early Development Laboratories Inc, Madison, WI, USA., Greiter-Wilke A; Roche Pharma Research and Early Development, Basel, Switzerland., Leishman D; Eli Lilly and Company, Indianapolis, IN, USA., Li D; Pfizer, Inc, Groton, CT, USA., Nichols JV; Labcorp Early Development Laboratories Inc, Madison, WI, USA., Pierson J; Health and Environmental Sciences Institute (HESI), Washington, DC, USA., Rossman EI; GSK, King of Prussia, PA, USA., Valentin JP; UCB Biopharma SPRL, Brussels, Belgium., Vicente J; Center for Drug Evaluation and Research, US Food & Drug Administration (FDA), Silver Spring, MD, USA., Walisser J; Labcorp Early Development Laboratories Inc, Madison, WI, USA., Troncy E; GREPAQ (Groupe de recherche en pharmacologie animale du Québec), Université de Montréal, St-Hyacinthe, Québec, Canada., Wisialowski TA; Pfizer, Inc, Groton, CT, USA.

Publikováno v: Journal of pharmacological and toxicological methods [J Pharmacol Toxicol Methods] 2024 Sep-Oct; Vol. 129, pp. 107543. Date of Electronic Publication: 2024 Jul 15.

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Akademický článek

Improving the in vivo QTc assay: Nonclinical concentration-QTc modeling for risk assessment.

Autor: Wisialowski TA; Pfizer, Groton, CT, USA. Electronic address: todd.a.wisialowski@pfizer.com., Ether N; Amgen Inc., Thousand Oaks, CA, USA., Foley CM; AbbVie, North Chicago, IL, USA., Kleiman R; Clario, Philadelphia, PA, USA., Koshman Y; AbbVie, North Chicago, IL, USA., Leishman D; Eli Lilly and Company, Indianapolis, IN, USA., Martel E; Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany., Nichols JV; Labcorp, Madison, WI, USA., Popp J; Labcorp, Madison, WI, USA., Rajamani S; Johnson & Johnson Innovative Medicine, CA, USA., Riley S; Pfizer, Groton, CT, USA., Rossman EI; GSK, Collegeville, PA, USA., Vargas HM; Amgen Inc., Thousand Oaks, CA, USA.

Publikováno v: Journal of pharmacological and toxicological methods [J Pharmacol Toxicol Methods] 2024 Jul-Aug; Vol. 128, pp. 107515. Date of Electronic Publication: 2024 May 20.

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Akademický článek

Best practice considerations for nonclinical in vivo cardiovascular telemetry studies in non-rodent species: Delivering high quality QTc data to support ICH E14/S7B Q&As.

Autor: Rossman EI; GSK, Nonclinical Safety, Safety Pharmacology, Collegeville, PA, USA. Electronic address: eric.i.rossman@gsk.com., Wisialowski TA; Pfizer Worldwide Research Development and Medical, Safety Pharmacology, Groton, CT, USA., Vargas HM; Amgen Research, Translational Safety & Bioanalytical Sciences, Thousand Oaks, CA, USA., Valentin JP; UCB Biopharma SRL, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium., Rolf MG; AstraZeneca, Clinical Pharmacology & Safety Sciences, R&D, Gothenburg, Sweden., Roche BM; Charles River Laboratories, Global Safety Pharmacology, Ashland, OH, USA., Riley S; Pfizer Worldwide Research Development and Medical, Clinical Pharmacology, Groton, CT, USA., Pugsley MK; Cytokinetics, Toxicology, South San Francisco, CA, USA., Nichols J; Labcorp Early Development Laboratories Inc., Madison, WI, USA., Li D; Pfizer Global Product Development, Global Biometrics & Data Management, Groton, CT, USA., Leishman DJ; Eli Lilly and Company, Indianapolis, IN, USA., Kleiman RB; Clario, Philadelphia, PA, USA., Greiter-Wilke A; Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Gintant GA; NuPharma Consulting, LLC, USA., Engwall MJ; Amgen Research, Translational Safety & Bioanalytical Sciences, Thousand Oaks, CA, USA., Delaunois A; UCB Biopharma SRL, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium., Authier S; Charles River Laboratories, Laval, QC, Canada.

Publikováno v: Journal of pharmacological and toxicological methods [J Pharmacol Toxicol Methods] 2023 Sep-Oct; Vol. 123, pp. 107270. Date of Electronic Publication: 2023 May 08.

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Akademický článek

Improving the in Vivo QTc assay: The value of implementing best practices to support an integrated nonclinical-clinical QTc risk assessment and TQT substitute.

Autor: Vargas HM; Amgen Research, Translational Safety & Bioanalytical Sciences, Thousand Oaks, CA 91320, USA. Electronic address: hvargas@amgen.com., Rossman EI; GlaxoSmithKline, Collegeville, PA 19426, USA., Wisialowski TA; Pfizer Worldwide Research, Development and Medical, Safety Pharmacology, Groton, CT, USA., Nichols J; Labcorp Early Development Laboratories Inc., Madison, WI, USA., Pugsley MK; Cytokinetics, Toxicology, South San Francisco, CA, USA., Roche B; Charles River Laboratories, Global Safety Pharmacology, Ashland, OH, USA., Gintant GA; NuPharma Consulting, LLC, USA., Greiter-Wilke A; Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Kleiman RB; Clario, Philadelphia, PA, USA., Valentin JP; UCB Biopharma SPRL, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium., Leishman DJ; Eli Lilly and Company, Indianapolis, IN, USA.

Publikováno v: Journal of pharmacological and toxicological methods [J Pharmacol Toxicol Methods] 2023 May-Jun; Vol. 121, pp. 107265. Date of Electronic Publication: 2023 Mar 28.

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