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Points to consider regarding the use and implementation of virtual controls in nonclinical general toxicology studies.

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作者单位: Drug Safety Research and Development, Pfizer Inc, 445, Eastern Point Road, Groton CT, USA. Electronic address: xavier.palazzi@pfizer.com. [1] Safety Assessment, Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA. [2] Nonclinical Drug Safety, Boehringer Ingelheim, 900 Ridgebury Road, Ridgefield, CT, 06877, USA. [3] Preclinical Safety, Novartis AG, Fabrikstrasse, Basel, Switzerland. [4] Preclinical Safety, AbbVie, 1 North Waukegan Road, R46G/AP13A-3, North Chicago, IL, 60064, USA. [5] Preclinical Safety, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936, USA. [6] Nonclinical Drug Safety, Merck and Co., Inc., Rahway, NJ, USA. [7] Clinical Pharmacology and Safety Sciences, AstraZeneca, Biomedical Campus, 1 Francis Crick Ave, Cambridge, UK. [8] Nonclinical Safety, Bristol Myers Squibb, 1 Squibb Dr, New Brunswick, NJ, 08901, USA. [9] Non-Clinical Safety, GSK, 1250 S. Collegeville Rd, Collegeville, PA, USA. [10] Translational Safety & Bioanalytical Sciences, Amgen, Inc., 1 Amgen Center Dr, Thousand Oaks, CA, 91320, USA. [11] Global Biometrics & Data Management, Pfizer Inc, 445, Eastern Point Road, Groton CT, USA. [12] Pharmaceutical Sciences, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070, Basel, Switzerland. [13] iBAR ADMET, Eli Lilly and Company, 893 Delaware St, Indianapolis, IN, USA. [14] Preclinical Sciences and Translational Safety, Johnson & Johnson, 1400 McKean Road, PO Box 776, Spring House, PA, 19477, USA. [15] Non-Clinical Safety, GSK, Gunnels Wood Road, Stevenage, SG1 2NY, UK. [16] Nonclinical Development, Organon, 4000 Chemical Rd, Suite 500, Plymouth Meeting, PA, 19462, USA. [17] Investigational Toxicology, BAYER AG, Pharmaceuticals, Muellerstrasse 178, 13342, Berlin, Germany. [18] Toxicology and Pathology, Agios Pharmaceuticals, 88 Sidney Street, Cambridge, MA, USA. [19]
DOI 10.1016/j.yrtph.2024.105632
PMID 38679316
发布时间 2024-06-10
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