eTRANSAFE: data science to empower translational safety assessment

F Sanz, F Pognan, T Steger-Hartmann, C Díaz… - Nature Reviews Drug …, 2023 - nature.com
eTRANSAFE: data science to empower translational safety assessment Skip to main content
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[HTML][HTML] Using historical control data in bioassays for regulatory toxicology

FM Kluxen, K Weber, C Strupp, SM Jensen… - Regulatory Toxicology …, 2021 - Elsevier
Historical control data (HCD) consist of pooled control group responses from bioassays.
These data must be collected and are often used or reported in regulatory toxicology studies …

[HTML][HTML] Replacing concurrent controls with virtual control groups in rat toxicity studies

A Gurjanov, C Vieira-Vieira, J Vienenkoetter… - Regulatory Toxicology …, 2024 - Elsevier
Virtual control groups (VCGs) in nonclinical toxicity represent the concept of using
appropriate historical control data for replacing concurrent control group animals. Historical …

A call for a human exposome project

T Hartung - ALTEX-Alternatives to animal experimentation, 2023 - altex.org
Four decades of the Human Genome Project and its consequences have shown how the
entrepreneurial state, through significant investment into science, can drive scientific …

Hurdles and signposts on the road to virtual control groups—a case study illustrating the influence of anesthesia protocols on electrolyte levels in rats

A Gurjanov, A Kreuchwig, T Steger-Hartmann… - Frontiers in …, 2023 - frontiersin.org
Introduction: Virtual Control Groups (VCGs) represent the concept of using historical control
data from legacy animal studies to replace concurrent control group (CCG) animals. Based …

Diabetes increases risk of lumbar spinal fusion complications: association with altered structure of newly formed bone at the fusion site

C Wilson, PJ Czernik, H Elgafy, S Khuder… - JBMR plus, 2024 - academic.oup.com
Diabetes predisposes to spine degenerative diseases often requiring surgical intervention.
However, the statistics on the prevalence of spinal fusion success and clinical indications …

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

X Palazzi, LT Anger, T Boulineau, A Grevot… - Regulatory toxicology …, 2024 - Elsevier
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 …

Toward implementing virtual control groups in nonclinical safety studies: Workshop report and roadmap to implementation

E Golden, D Allen, A Amberg, LT Anger, E Baker… - 2023 - kops.uni-konstanz.de
Historical data from control groups in animal toxicity studies are currently mainly used for
comparative purposes to assess validity and robustness of study results. Due to the highly …

The eTRANSAFE project on translational safety assessment through integrative knowledge management: achievements and perspectives

F Pognan, T Steger-Hartmann, C Díaz, N Blomberg… - Pharmaceuticals, 2021 - mdpi.com
eTRANSAFE is a research project funded within the Innovative Medicines Initiative (IMI),
which aims at develo** integrated databases and computational tools (the eTRANSAFE …

[HTML][HTML] Retrospective analysis of the potential use of virtual control groups in preclinical toxicity assessment using the eTOX database

PSR Wright, GF Smith, KA Briggs, R Thomas… - Regulatory Toxicology …, 2023 - Elsevier
Abstract Virtual Control Groups (VCGs) based on Historical Control Data (HCD) in
preclinical toxicity testing have the potential to reduce animal usage. As a case study we …