Thanks for your answer, but we either don't understand the biology of the animal models that we use.

I think that medicine and drug regulations do not use the same conceptual framework as biology. Medicine and drug regulations are pragmatic, hence the concept of clinical trial: They test if something works while minimizing the confounding factors. They do not try to understand the biology down to cellular force fields of the animal model.

So why not have the same approach with software? Anyway, drugs authorities have already approved drugs based on software simulations [0, 1].

[0] https://www.fda.gov/media/163156/download

[1] https://www.fda.gov/science-research/about-science-research-...