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

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Title: Reevaluating safety pharmacology respiratory studies within the ICH S7A core battery: A multi-company evaluation of preclinical utility and clinical translation.
Authors: 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.
Source: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 Nov; Vol. 153, pp. 105706. Date of Electronic Publication: 2024 Sep 16.
Publication Type: Journal Article
Journal Info: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1096-0295 (Electronic) Linking ISSN: 02732300 NLM ISO Abbreviation: Regul Toxicol Pharmacol Subsets: MEDLINE
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  Data: Reevaluating safety pharmacology respiratory studies within the ICH S7A core battery: A multi-company evaluation of preclinical utility and clinical translation.
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  Data: <searchLink fieldCode="AU" term="%22Friedrichs+GS%22">Friedrichs GS</searchLink>; Novartis Biomedical Research, 1 Health Plaza, East Hanover, NJ 07936-1080, USA. Electronic address: greg.friedrichs@novartis.com.<br /><searchLink fieldCode="AU" term="%22Abernathy+MM%22">Abernathy MM</searchLink>; Eli Lilly Corporate Center, 893 Delaware St, Indianapolis, IN 46225, USA.<br /><searchLink fieldCode="AU" term="%22Ackley+D%22">Ackley D</searchLink>; Eli Lilly Corporate Center, 893 Delaware St, Indianapolis, IN 46225, USA.<br /><searchLink fieldCode="AU" term="%22Clark+M%22">Clark M</searchLink>; Ability Biologics, 3 Place Ville-Marie Suite 400, Montréal, Québec H3B 4W8, Canada.<br /><searchLink fieldCode="AU" term="%22DaSilva+JK%22">DaSilva JK</searchLink>; Pfizer Research and Development, 445 Eastern Point Rd Groton, CT 06340, USA.<br /><searchLink fieldCode="AU" term="%22Foley+CM%22">Foley CM</searchLink>; Abbvie Inc, North Chicago, IL, 60064, USA.<br /><searchLink fieldCode="AU" term="%22Greiter-Wilke+A%22">Greiter-Wilke A</searchLink>; Roche Innovation Center Basel, Grenzacherstr. 124, CH 4070 Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Henderson+KA%22">Henderson KA</searchLink>; Amgen Inc., Translational Safety & Bioanalytical Sciences, Thousand Oaks, CA 91320, USA.<br /><searchLink fieldCode="AU" term="%22Kremer+JJ%22">Kremer JJ</searchLink>; Novartis BioMedical Research, 220 Massachusetts Avenue, Cambridge, MA 02139, USA.<br /><searchLink fieldCode="AU" term="%22Morimoto+BH%22">Morimoto BH</searchLink>; Alto Neuroscience, Inc. 369 S San Antonio Rd, Los Altos CA 94022, USA.<br /><searchLink fieldCode="AU" term="%22Paglialunga+S%22">Paglialunga S</searchLink>; Celerion, 2420 W Baseline Rd, Tempe, AZ 85283, USA.<br /><searchLink fieldCode="AU" term="%22Pugsley+MK%22">Pugsley MK</searchLink>; Cytokinetics, 350 Oyster Point Blvd, South San Francisco, CA 94080, USA.<br /><searchLink fieldCode="AU" term="%22Regan+CP%22">Regan CP</searchLink>; Merck & Co., Inc., West Point, PA 19486, USA.<br /><searchLink fieldCode="AU" term="%22Rossman+EI%22">Rossman EI</searchLink>; GSK, 1250 Collegeville Avenue, Collegeville, PA 19426, USA.<br /><searchLink fieldCode="AU" term="%22Segretti+JA%22">Segretti JA</searchLink>; Abbvie Inc, North Chicago, IL, 60064, USA.<br /><searchLink fieldCode="AU" term="%22Traebert+M%22">Traebert M</searchLink>; Novartis BioMedical Research, Postfach, 4002 Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Vargas+HM%22">Vargas HM</searchLink>; Amgen Inc., Translational Safety & Bioanalytical Sciences, Thousand Oaks, CA 91320, USA.<br /><searchLink fieldCode="AU" term="%22Wisialowski+TA%22">Wisialowski TA</searchLink>; Pfizer Research and Development, 445 Eastern Point Rd Groton, CT 06340, USA.
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  Data: <searchLink fieldCode="JN" term="%228214983%22">Regulatory toxicology and pharmacology : RTP</searchLink> [Regul Toxicol Pharmacol] 2024 Nov; Vol. 153, pp. 105706. <i>Date of Electronic Publication: </i>2024 Sep 16.
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