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


Journal

Regulatory toxicology and pharmacology : RTP
ISSN: 1096-0295
Titre abrégé: Regul Toxicol Pharmacol
Pays: Netherlands
ID NLM: 8214983

Informations de publication

Date de publication:
26 Apr 2024
Historique:
received: 12 02 2024
revised: 17 04 2024
accepted: 22 04 2024
medline: 29 4 2024
pubmed: 29 4 2024
entrez: 28 4 2024
Statut: aheadofprint

Résumé

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.

Identifiants

pubmed: 38679316
pii: S0273-2300(24)00073-4
doi: 10.1016/j.yrtph.2024.105632
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

105632

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

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. ☐ The author is an Editorial Board Member/Editor-in-Chief/Associate Editor/Guest Editor for [Journal name] and was not involved in the editorial review or the decision to publish this article. ☐ The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:

Auteurs

Xavier Palazzi (X)

Drug Safety Research and development, Pfizer Inc, 445, Eastern Point Road, Groton CT, USA.

Lennart T Anger (LT)

Safety Assessment, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.

Theresa Boulineau (T)

Nonclinical Drug Safety, Boehringer Ingelheim, 900 Ridgebury Road, Ridgefield, CT, 06877.

Armelle Grevot (A)

Preclinical Safety, Novartis AG, Fabrikstrasse, Basel, Switzerland.

Magali Guffroy (M)

Preclinical Safety, AbbVie, 1 North Waukegan Road, R46G/AP13A-3, North Chicago, Illinois 60064.

Kristin Henson (K)

Preclinical Safety, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936.

Natalie Hoepp (N)

Nonclinical Drug Safety, Merck and Co., Inc., Rahway, NJ, US.

Matt Jacobsen (M)

Clinical Pharmacology and Safety Sciences, AstraZeneca, Biomedical Campus, 1 Francis Crick Ave, Cambridge, UK.

Vijay P Kale (VP)

Nonclinical Safety, Bristol Myers Squibb, 1 Squibb Dr, New Brunswick, NJ 08901.

John Kreeger (J)

Non-Clinical Safety, GSK, 1250 S. Collegeville Rd. Collegeville, PA, USA.

Joan H Lane (JH)

Translational Safety & Bioanalytical Sciences, Amgen, Inc., 1 Amgen Center Dr, Thousand Oaks, CA 91320, USA.

Dingzhou Li (D)

Global Biometrics & Data Management, Pfizer Inc, 445, Eastern Point Road, Groton CT, USA.

Wolfgang Muster (W)

Pharmaceutical Sciences, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland.

Brianna Paisley (B)

iBAR ADMET, Eli Lilly and Company, 893 Delaware St, Indianapolis, IN, US.

Lila Ramaiah (L)

Preclinical Sciences and Translational Safety, Johnson & Johnson, 1400 McKean Road, PO Box 776, Spring House, PA, 19477.

Nicola Robertson (N)

Non-Clinical Safety, GSK, Gunnels Wood Road, Stevenage, SG1 2NY, UK.

Valerie Shultz (V)

Nonclinical Development, Organon, 4000 Chemical Rd, Suite 500, Plymouth Meeting, PA 19462.

Thomas Steger Hartmann (T)

Investigational Toxicology, BAYER AG, Pharmaceuticals, Muellerstrasse 178, 13342 Berlin, Germany.

Richard Westhouse (R)

Toxicology and Pathology, Agios Pharmaceuticals, 88 Sidney Street, Cambridge, MA.

Classifications MeSH