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
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.