• 1.
    Steger-Hartmann T, Kreuchwig A, Vaas L, Wichard J, Bringezu F, Amberg A, Muster W, Pognan F, Barber C. Introducing the concept of virtual control groups into preclinical toxicology testing. ALTEX. 2020;37(3):343-349. READ


  • 2.
    Wright PSR, Smith GF, Briggs KA, Thomas R, Maglennon G, Mikulskis P, Chapman M, Greene N, Phillips BU, Bender A. Retrospective analysis of the potential use of virtual control groups in preclinical toxicity assessment using the eTOX database. egul Toxicol Pharmacol. 2023 Feb;138:105309. READ


  • 3.
    Mecklenburg L, Lenz S, Hempel G. How important are concurrent vehicle control groups in (sub)chronic non-human primate toxicity studies conducted in pharmaceutical development? An opportunity to reduce animal numbers. PLoS One. 2023 Aug 3;18(8):e0282404. READ


  • 4.
    Gurjanov A, Kreuchwig A, Steger-Hartmann T, Vaas LAI. Hurdles and signposts on the road to virtual control groups-A case study illustrating the influence of anesthesia protocols on electrolyte levels in rats. Front Pharmacol. 2023 Apr 20;14:1142534. READ


  • 5.
    Steger-Hartmann T, Clark M. Can Historical Control Group Data Be Used to Replace Concurrent Controls in Animal Studies?. Toxicol Pathol. 2023 Aug;51(6):361-362. READ


  • 6.
    Grevot A, Boisclair J, Guffroy M, Hall P, Pohlmeyer-Esch G, Jacobsen M, Bach U, Frisk AL, Dybdal N, Palazzi X. Toxicologic Pathology Forum Opinion Piece: Use of Virtual Control Groups in Nonclinical Toxicity Studies: The Anatomic Pathology Perspective. Toxicol Pathol. 2023 Aug;51(6):390-396. READ


  • 7.
    Sanz F, Pognan F, Steger-Hartmann T, Díaz C, et al. eTRANSAFE: data science to empower translational safety assessment. Nat Rev Drug Discov. 2023 Aug;22(8):605-606. READ


  • 8.
    Golden E, Allen D, Amberg A, Anger LT, Baker E, Baran SW, Bringezu F, Clark M, Duchateau-Nguyen G, Escher SE, Giri V, Grevot A, Hartung T, Li D, Lotfi L, Muster W, Snyder K, Wange R, Steger-Hartmann T. Toward implementing virtual control groups in nonclinical safety studies: Workshop report and roadmap to implementation. ALTEX. 2024;41(2):282-301. READ


  • 9.
    Gurjanov A, Vieira-Vieira C, Vienenkoetter J, Vaas LAI, Steger-Hartmann T. Replacing concurrent controls with virtual control groups in rat toxicity studies. Regul Toxicol Pharmacol. 2024 Mar;148:105592. READ


  • 10.
    Gurjanov A, Vaas LAI, Steger-Hartmann T. The road to virtual control groups and the importance of proper body-weight selection. ALTEX. 2024;41(4):660-665. READ


  • 11.
    Palazzi X, Anger LT, Boulineau T, Grevot A, Guffroy M, Henson K, Hoepp N, Jacobsen M, Kale VP, Kreeger J, Lane JH, Li D, Muster W, Paisley B, Ramaiah L, Robertson N, Shultz V, Steger Hartmann T, Westhouse R. Points to consider regarding the use and implementation of virtual controls in nonclinical general toxicology studies. Regul Toxicol Pharmacol. 2024 Jun;150:105632. READ


  • 12.
    Andaya R, Sullivan R, Pourmohamad T, Hayes M, Maliver P, Laing S, Hasselgren C, Dybdal N, Adedeji AO, Anger LT. A proof-of-concept rat toxicity study highlights the potential utility and challenges of virtual control groups. ALTEX. 2024;41(4):647-659. READ


  • 13.
    Hartung T, King NMP, Kleinstreuer N, Leist M, Tagle DA. Leveraging biomarkers and translational medicine for preclinical safety – Lessons for advancing the validation of alternatives to animal testing. ALTEX. 2024;41(4):545–66. READ


  • 14.
    Hartung T. The validation of regulatory test methods – Conceptual, ethical, and philosophical foundations. ALTEX. 2024;41(4):525–44. READ


  • 15.
    Li D, Garren J, Mangipudy R, Martin M, Tomlinson L, Vansell NR. Statistical applications of virtual control groups to nonrodent animal toxicity studies: An initial evaluation. Regul Toxicol Pharmacol. 2024 Dec;154:105733. READ


  • 16.
    Guffroy M, Arndt T, Barale-Thomas E, Bolin S, Grevot A, Ibanes J, Laing ST, Leach MW, Meindel M, Palazzi X, Ramaiah L, Schwartz J, Johnson RL. Scientific and Regulatory Policy Committee Points to Consider: Proposal and Recommendations to Reduce Euthanasia of Control Nonhuman Primates in Nonclinical Toxicity Studies. Toxicol Pathol. 2025. READ


  • 17.
    Adedeji AO, Naor AW. Virtual Control Groups in Non-clinical Toxicity Studies: Impacts on Toxicologic Clinical Pathology Data Interpretation. Toxicol Pathol. 2025 Feb;53(2):164-172. READ


  • 18.
    Wise LD, Hoberman AM, Bowman CJ, Lewis EM. Perspectives on Implementing Virtual Control Groups in Developmental and Reproductive Toxicity Studies. Birth Defects Res. 2025 May;117(5):e2479. READ


  • 19.
    Cöllen E, Bartmann K, Blum J, Carstens K, Celardo I, Chatterjee N, Corvaro M, Dreser N, Fritsche E, Hartung T, Hogberg HT, Knudsen T, Koch K, Kreutz A, Lislien M, Magel V, Marty MS, Pallocca G, Bal-Price A, Rovida C, Sachana M, Shafer TJ, Smirnova L, Suciu I, Tanaskov Y, Tangianu S, Wolfbeisz C, Leist M. Mapping out strategies to further develop human-relevant, new approach methodology (NAM)-based developmental neurotoxicity (DNT) testing. ALTEX. 2025;42(2):308-322. READ


  • 20.
    Chibout SD, Brees D, Chlebus M, Detilleux P, Laplanche L, Moggs J, Ramaiah SK, Richard J, Schütz G, Seigneuret N, Steger-Hartmann T, Vaudano E. Innovative Medicines Initiative public–private partnerships to enhance translational safety. Nat Rev Drug Discov. 2025 May 22. READ