Current practices on the measurement of electrocardiogram and hemodynamic parameters in non-rodent species in regulatory safety assessment studies.

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Title: Current practices on the measurement of electrocardiogram and hemodynamic parameters in non-rodent species in regulatory safety assessment studies.
Authors: Valentin JP; Early Clinical Development & Translational Science, Non-Clinical Safety Evaluation, UCB, Braine L'Alleud, Belgium. Electronic address: jean-pierre.valentin@ucb.com., Bourcier T; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, USA.; Todd Bourcier Current Contact Information is 'White Oak Regulatory Tox, LLC, Crownsville, MD 21032, USA.. Electronic address: todd.bourcier@whiteoakregtox.com., Chi X; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, USA.. Electronic address: Xuan.Chi@fda.hhs.gov., Delaunois A; Early Clinical Development & Translational Science, Non-Clinical Safety Evaluation, UCB, Braine L'Alleud, Belgium. Electronic address: annie.delaunois@ucb.com., Foley CM; Preclinical Safety/Safety Pharmacology, AbbVie Inc., North Chicago, IL 60064, USA.. Electronic address: michael.foley@abbvie.com., Henderson KA; Amgen Research, Translational Safety & Bioanalytical Sciences, Thousand Oaks, CA 91320, USA.. Electronic address: khende02@amgen.com., Lainee P; Sanofi Research and Development, Translational Models, Montpellier, France.. Electronic address: pierre.lainee@sanofi.com., Leishman DJ; Drug Disposition, Toxicology and PKPD, Eli Lilly and Company, Indianapolis, IN 46285, USA.. Electronic address: derek.leishman@lilly.com., Li D; Pfizer Research and Development, Eastern Point Road, Groton, CT 06340, USA.. Electronic address: dingzhou.li@pfizer.com., Pawluk E; Early Clinical Development & Translational Science, Non-Clinical Safety Evaluation, UCB, Braine L'Alleud, Belgium. Electronic address: emma.pawluk@ucb.com., Pugsley MK; Cytokinetics, Toxicology & Safety Pharmacology, South San Francisco, CA 85024, USA.. Electronic address: mpugsley@cytokinetics.com., Rajamani S; Johnson & Johnson Innovative Medicine, 3120 Merryfield Row, San Diego, CA 92121, USA.. Electronic address: srajama3@its.jnj.com., Regan CP; Nonclinical Drug Safety Merck & Co., Inc., Rahway, NJ 07065, USA.. Electronic address: christopher_regan@merck.com., Rolf MG; AstraZeneca R&D, Pepparedsleden 1, 431 83 Mölndal, Sweden. Electronic address: mike.rolf@astrazeneca.com., Ross R; Labcorp, Madison, WI 53704, USA.. Electronic address: rebecca.ross@labcorp.com., Rossman EI; GSK, Safety Pharmacology, Collegeville, PA 19426, USA.. Electronic address: eric.i.rossman@gsk.com., Tichenor SD; Charles River Laboratories, 6995 Longley Lane, Reno, NV 89511, USA.. Electronic address: steve.tichenor@crl.com., Villar IC; AstraZeneca R&D, The Discovery Centre, 1 Francis Crick Avenue, Cambridge CB20AA, UK. Electronic address: conchi.villarmoas@astrazeneca.com., Wisialowski TA; Pfizer Research and Development, Eastern Point Road, Groton, CT 06340, USA.. Electronic address: todd.a.wisialowski@pfizer.com., Wu J; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, USA.. Electronic address: jean.wu@fda.hhs.gov., Vargas HM; Amgen Research, Translational Safety & Bioanalytical Sciences, Thousand Oaks, CA 91320, USA.. Electronic address: hvargas@amgen.com.
Source: Journal of pharmacological and toxicological methods [J Pharmacol Toxicol Methods] 2025 Sep; Vol. 135, pp. 107765. Date of Electronic Publication: 2025 Jun 19.
Publication Type: Journal Article
Journal Info: Publisher: Elsevier Country of Publication: United States NLM ID: 9206091 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-488X (Electronic) Linking ISSN: 10568719 NLM ISO Abbreviation: J Pharmacol Toxicol Methods Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1873-488X
DOI:10.1016/j.vascn.2025.107765