Perspectives of data science in preclinical safety assessment

A minimal metadata set (MNMS) to repurpose nonclinical in vivo data for biomedical research

“… 23 and more recently ref. 24 ). As further publications on VCGs emerge from this project, additional lessons and insights will undoubtedly further support the practical implementation of VCGs in the biomedical research field.…”

“…22 )). Likewise, the FDA has implemented SEND for standardized reporting of nonclinical safety studies, while the recently concluded IMI eTRANSAFE project has advanced data sharing to improve translational safety assessments in drug development 24 .…”

Editorial: Advances in and applications of predictive toxicology: 2022

“…Together these regulatory changes offer the possibility of replacing animal testing in drug development with suitably validated Predictive Toxicology methods.Currently, Predictive Toxicology uses and integrates in silico, in chemico and in vitro approaches named "New Approach Methodologies (NAMs)" to predict the potential toxic effects of a chemical or drug on living organisms including humans, as well as to assess the safety and potential risks associated with exposure to chemicals, drugs, environmental pollutants, and other substances. Predictive Toxicology forms the backbone of the chemical next-generation risk assessment (NGRA), which integrates NAMs to assure human safety without animal testing (Alexander-White et al, 2022).The main areas delivering contributions to Predictive Toxicology with probably the greatest recent advancements are micro-physiological systems (MPS) (Roth, 2021), sometimes also termed as advanced cellular models (Pineiro-Llanes et al, 2023), new approaches in data science including analysis of omics data and systems toxicology (Steger-Hartmann et al, 2023), as well as physiologically based pharmacokinetic/toxicokinetic modeling and simulation. The progress in these areas is also illustrated through the manuscripts submitted to this Research Topic of Frontiers in Toxicology:Cairns et al present an important milestone in implementing MPS in efficient toxicity testing of drugs.…”

Can Historical Control Group Data Be Used to Replace Concurrent Controls in Animal Studies?

“…5 Since then, initiatives have been undertaken to explore, what challenges the concept might create and what requirements are needed to eventually implement the concept. 3,6 It has already become evident that the control data potentially used for VCGs require much more scrutiny and curation compared to HCD. Historical control data are usually collected from a single test site by selecting all control animals from recent studies which have been performed timely close to the study under evaluation.…”

“…For VCGs, it has already been recognized that not only these parameters but substantially more need to be tightly controlled and adequately matched with the treatment groups at day 1 of a study to avoid negative impacts on study outcome. For example, it was shown that a change of the anesthesia procedure used for blood withdrawal Toxicologic Pathology 51 (6) affects the cation measurements in clinical pathology. If this is not adequately captured and considered during the selection of control data for VCGs, the identification of treatment-related findings affecting potassium or calcium levels in serum might be impaired.…”