Translation and validation

Benjamin V. Ineichen, Eva Furrer, Servan L. Grüninger, Wolfgang E. Zürrer, Malcolm R. Macleod. Analysis of animal-to-human translation shows that only 5% of animal-tested therapeutic interventions obtain regulatory approval for human applications. PLOS Biology. 22(6):e3002667. doi:10.1371/journal.pbio.3002667

Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Validation Workgroup. Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies. Interagency Coordinating Committee on the Validation of Alternative Methods; :75. https://ntp.niehs.nih.gov/sites/default/files/2024-03/VWG_Report_27Feb2024_FD_508.pdf.

Pandora Pound, Christine J. Nicol. Retrospective harm benefit analysis of pre-clinical animal research for six treatment interventions. PLOS ONE. 13(3):e0193758. doi:10.1371/journal.pone.0193758

H. Bart van der Worp, David W. Howells, Emily S. Sena, et al. Can Animal Models of Disease Reliably Inform Human Studies?. PLOS Medicine. 7(3):e1000245. doi:10.1371/journal.pmed.1000245

Emily S. Sena, H. Bart van der Worp, Philip M. W. Bath, David W. Howells, Malcolm R. Macleod. Publication Bias in Reports of Animal Stroke Studies Leads to Major Overstatement of Efficacy. PLOS Biology. 8(3):e1000344. doi:10.1371/journal.pbio.1000344

Constance Holman, Sophie K. Piper, Ulrike Grittner, et al. Where Have All the Rodents Gone? The Effects of Attrition in Experimental Research on Cancer and Stroke. PLOS Biology. 14(1):e1002331. doi:10.1371/journal.pbio.1002331

Alper Öztürk, Halis Atıl Atilla. In Musculoskeletal Research, Too Many Animals are Being Harmed for Too Small a Return. Clinical Orthopaedics and Related Research. 482(5):899-900. doi:10.1097/CORR.0000000000003037

Linda Bunschoten. The Real Cost of Delays in Drug Development and the Role of RBQM and QbD. https://cyntegrity.com/the-real-cost-of-delays-in-drug-development-and-the-role-of-rbqm-and-qbd.