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

Autor: Palazzi X; Drug Safety Research and Development, Pfizer Inc, 445, Eastern Point Road, Groton CT, USA. Electronic address: xavier.palazzi@pfizer.com., Anger LT; Safety Assessment, Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA., Boulineau T; Nonclinical Drug Safety, Boehringer Ingelheim, 900 Ridgebury Road, Ridgefield, CT, 06877, USA., Grevot A; Preclinical Safety, Novartis AG, Fabrikstrasse, Basel, Switzerland., Guffroy M; Preclinical Safety, AbbVie, 1 North Waukegan Road, R46G/AP13A-3, North Chicago, IL, 60064, USA., Henson K; Preclinical Safety, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936, USA., Hoepp N; Nonclinical Drug Safety, Merck and Co., Inc., Rahway, NJ, USA., Jacobsen M; Clinical Pharmacology and Safety Sciences, AstraZeneca, Biomedical Campus, 1 Francis Crick Ave, Cambridge, UK., Kale VP; Nonclinical Safety, Bristol Myers Squibb, 1 Squibb Dr, New Brunswick, NJ, 08901, USA., Kreeger J; Non-Clinical Safety, GSK, 1250 S. Collegeville Rd, Collegeville, PA, USA., Lane JH; Translational Safety & Bioanalytical Sciences, Amgen, Inc., 1 Amgen Center Dr, Thousand Oaks, CA, 91320, USA., Li D; Global Biometrics & Data Management, Pfizer Inc, 445, Eastern Point Road, Groton CT, USA., Muster W; Pharmaceutical Sciences, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070, Basel, Switzerland., Paisley B; iBAR ADMET, Eli Lilly and Company, 893 Delaware St, Indianapolis, IN, USA., Ramaiah L; Preclinical Sciences and Translational Safety, Johnson & Johnson, 1400 McKean Road, PO Box 776, Spring House, PA, 19477, USA., Robertson N; Non-Clinical Safety, GSK, Gunnels Wood Road, Stevenage, SG1 2NY, UK., Shultz V; Nonclinical Development, Organon, 4000 Chemical Rd, Suite 500, Plymouth Meeting, PA, 19462, USA., Steger Hartmann T; Investigational Toxicology, BAYER AG, Pharmaceuticals, Muellerstrasse 178, 13342, Berlin, Germany., Westhouse R; Toxicology and Pathology, Agios Pharmaceuticals, 88 Sidney Street, Cambridge, MA, USA.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 Jun; Vol. 150, pp. 105632. Date of Electronic Publication: 2024 Apr 27.
DOI: 10.1016/j.yrtph.2024.105632
Abstrakt: The replacement of a proportion of concurrent controls by virtual controls in nonclinical safety studies has gained traction over the last few years. This is supported by foundational work, encouraged by regulators, and aligned with societal expectations regarding the use of animals in research. This paper provides an overview of the points to consider for any institution on the verge of implementing this concept, with emphasis given on database creation, risks, and discipline-specific perspectives.
Competing Interests: Declaration of competing interest X The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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