We are working with a drug molecule with proven anticancer activity on the cancer cell lines.
We also have toxicity data of the same on mice. LD50 etc.
While developing an oral formulation with this drug we are unable to find any guidelines or any standard method (with reference) that should be followed for calculating effective human dose or a dose that should be used to develop the formulation.
It would be very helpful if someone can come up with a satisfactory answer.
Globally accepted guidelines for such calculation will be very helpful.
Otherwise, any published literature (which I failed to find) will be helpful.
If animal studies have been done there are some guidelines how to extrapolate dosage from animal studies. I found some papers on this topic: