Related Publications

37.
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

38.
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

39.
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

40.
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

41.
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

42.
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

43.
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

44.
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

45.
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

46.
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

47.
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

48.
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

49.
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

50.
Hartung T. The validation of regulatory test methods – Conceptual, ethical, and philosophical foundations. ALTEX. 2024;41(4):525–44. READ

51.
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

52.
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 Apr;53(3):287-296. READ

53.
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

54.
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

55.
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

56.
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

57.
Health and Environmental Sciences Institute (HESI Global). Building a Roadmap for AI-Enabled Human and Environmental Health Protection. Workshop Report. 2025 Jun. READ

58.
EFSA Panel on Plant Protection Products and their Residues (PPR). Use and reporting of historical control data for regulatory studies. EFSA Journal. 2025 Aug. READ

59.
Felli JK, Leishman DJ, Steeves MA. Using pre-existing control data to set expectations in preclinical studies. Regul Toxicol Pharmacol. 2025 Nov;162:105899. READ

61.
Hartung T, Smirnova L, Platz S Amelio I, Leist M. The need for epigenotoxicity testing. ALTEX. 2025;42(4):565-590. READ

62.
European Medicines Agency. Non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation – Scientific guideline. EMA. READ

63.
Rodríguez-Belenguer P, Amberg A, Bringezu F, Frericks M, Hemmerich J, Monecke P, Oberhauser N, Trairatphisan P, Pastor M. A Simple Framework for Collaborative Development of Predictive Models Trained on Proprietary Data. J Chem Inf Model. 2025 Nov 18. READ

64.
Barnhart K, Bolon B, Boone L, Fossey S, Grevot A, Hukkanen R, Ramaiah L, Schafer K. STP Town Hall Discussion on the Use of Virtual Control Groups in Nonclinical Toxicity Studies. Toxicol Pathol. 2025 Nov 18. READ

65.
Brumfield MA, Higson GC, Ollivier C, Seigneuret N. Delivering regulatory impact from consortium-based projects. Nat Rev Drug Discov. 2025 Jun 9. READ

66.
Bowman CJ, Li D, Tran TDB, Catlin NR, Stethem CM, Nowland WS, Campion SN. Exploration of virtual control groups and Bayesian approaches for rat fertility studies. Regul Toxicol Pharmacol. 2025 Nov 26:106004. READ

67.
Gen Sato, Takao Kurooka, Ikuro Takakura, Yuichiro Amano, Kuniyoshi Sakai, Satomi Nishikawa, Takashi Tanaharu, Keiko Motoyama, Kiyohiro Hashimoto, Mutsumi Suzuki. Interfacility Variations in Blood Chemistry Parameters and Their Implications for Virtual Control Group Construction. NAM Journal. Dec. 2025. READ

68.
European Medicines Agency, US Food and Drug Administration. Guiding principles of good AI practice in drug development. EMA. January 2026. READ

69.
Lotfi L, O'Neill TW, Wilcox A, Bulera S. Virtual Control Groups in Nonclinical Research: A Re-analysis of 20 Studies Using Virtual Control Group Data. Regul Toxicol Pharmacol. 2026 Feb 27. READ

70.
Kwon D. The age of animal experiments is waning. Where will science go next?. Nature. 2026 Feb;650(8103):812-814. READ

71.
LaFollette M, Roper C, Thompson-Iritani S. Never-ending Acronym Madness: Proposing a harmonized definition for NAMs. NAM Journal. Mar. 2026. READ

72.
Duchateau-Nguyen G, Piraino M, Draganov DI, Maliver P, Muster W, Stirn M and Piraino P. Analysis of rat toxicology studies: statistical agreement between virtual and concurrent controls in detecting treatment effects on liver enzymes. Front. Pharmacol. 17:1704002. READ