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Considerations from the pharmaceutical industry (IQ MPS Affiliate) workshop on animal microphysiological systems and 3Rs in drug development.

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Title: Considerations from the pharmaceutical industry (IQ MPS Affiliate) workshop on animal microphysiological systems and 3Rs in drug development.
Authors: Devine PJ; Discovery Toxicology, Bristol Myers Squibb, Cambridge, MA, USA., Guha M; Translational Medicine, Incyte, Wilmington, DE, USA., Ekert JE; UCB Pharma, Cambridge, MA, USA., Kopec AK; Drug Safety Research & Development, Pfizer, Inc., CT, USA., Gosset JR; Pharmacokinetics, Dynamics, and Metabolism, Pfizer, Inc., Cambridge, MA, USA., Freag MS; Takeda Pharmaceuticals, Cambridge, MA, USA., Wagoner MP; Takeda Pharmaceuticals, Cambridge, MA, USA., Hewitt P; Chemical and Nonclinical Safety, Merck Healthcare KGaA, Darmstadt, Germany., Harris K; National Centre for the Replacement, Refinement and Reduction of Animals in Research, London, UK., Lemmens M; Biomedical Research, Novartis, Basel, Switzerland., Sadrieh N; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, USA., Mendrick D; U.S. Food and Drug Administration, National Center for Toxicological Research, Jefferson, AR, USA., Stresser DM; AbbVie, Inc., N. Chicago, IL, USA., Valencia L; Safety Assessment, Genentech, San Francisco, CA, USA., Brown PC; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, USA., Wange RL; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, USA., Avila A; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, USA., Ford K; U.S. Food and Drug Administration, Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Silver Spring, MD, USA., Geiger R; U.S. Food and Drug Administration, Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Silver Spring, MD, USA., Garcia M; U.S. Food and Drug Administration, Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Silver Spring, MD, USA., Bonzo JA; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, USA., Gleeson JP; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, NJ, USA., Orozco CC; Pharmacokinetics, Dynamics, and Metabolism, Pfizer Worldwide Research and Development, Groton, CT, USA., Li Q; Advanced Translational Science & Management, Astellas Research Institute of America LLC, Northbrook, IL, USA., Hinckley C; Translational Medicine, Biogen Research, Biogen, Cambridge, MA, USA., Class R; DMPK-in vitro ADME, UCB Biopharma SRL, Brussels, Belgium., McAuliffe JM; Viral Vaccines, GSK, Rockville, MD, USA., Tran-Guzman A; Discovery Toxicology, Bristol Myers Squibb, San Diego, CA, USA., Nevelli F; Global Healthcare & Operation, Merck Healthcare KGaA, Ivrea, Italy., Gamboa da Costa G; U.S. Food and Drug Administration, National Center for Toxicological Research, Jefferson, AR, USA., Petibone D; U.S. Food and Drug Administration, National Center for Toxicological Research, Jefferson, AR, USA., Kiyota T; Safety Assessment, Genentech, San Francisco, CA, USA., Shi Q; U.S. Food and Drug Administration, National Center for Toxicological Research, Jefferson, AR, USA., Hardwick RN; Discovery Toxicology, Bristol Myers Squibb, San Diego, CA, USA.
Source: ALTEX [ALTEX] 2025; Vol. 42 (3), pp. 451-467. Date of Electronic Publication: 2025 Apr 11.
Publication Type: Journal Article
Journal Info: Publisher: Spektrum Akademischer Verlag Country of Publication: Germany NLM ID: 100953980 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1868-8551 (Electronic) Linking ISSN: 1868596X NLM ISO Abbreviation: ALTEX Subsets: MEDLINE
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  Data: <searchLink fieldCode="AU" term="%22Devine+PJ%22">Devine PJ</searchLink>; Discovery Toxicology, Bristol Myers Squibb, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Guha+M%22">Guha M</searchLink>; Translational Medicine, Incyte, Wilmington, DE, USA.<br /><searchLink fieldCode="AU" term="%22Ekert+JE%22">Ekert JE</searchLink>; UCB Pharma, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Kopec+AK%22">Kopec AK</searchLink>; Drug Safety Research & Development, Pfizer, Inc., CT, USA.<br /><searchLink fieldCode="AU" term="%22Gosset+JR%22">Gosset JR</searchLink>; Pharmacokinetics, Dynamics, and Metabolism, Pfizer, Inc., Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Freag+MS%22">Freag MS</searchLink>; Takeda Pharmaceuticals, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Wagoner+MP%22">Wagoner MP</searchLink>; Takeda Pharmaceuticals, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Hewitt+P%22">Hewitt P</searchLink>; Chemical and Nonclinical Safety, Merck Healthcare KGaA, Darmstadt, Germany.<br /><searchLink fieldCode="AU" term="%22Harris+K%22">Harris K</searchLink>; National Centre for the Replacement, Refinement and Reduction of Animals in Research, London, UK.<br /><searchLink fieldCode="AU" term="%22Lemmens+M%22">Lemmens M</searchLink>; Biomedical Research, Novartis, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Sadrieh+N%22">Sadrieh N</searchLink>; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Mendrick+D%22">Mendrick D</searchLink>; U.S. Food and Drug Administration, National Center for Toxicological Research, Jefferson, AR, USA.<br /><searchLink fieldCode="AU" term="%22Stresser+DM%22">Stresser DM</searchLink>; AbbVie, Inc., N. 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