4 ms·
After reading your links I think it is more clear that "optimal dose" does not mean optimal dose for the patient or total population. It is optimal dose such th
by handmodel 5y ago
After reading your links I think it is more clear that "optimal dose" does not mean optimal dose for the patient or total population. It is optimal dose such that a single phase III trial would detect a measurable effect.
Once its approved already at a set dose, the "ideal dose" for future use is probably not the same as the "optimal dose" that maximized probability of approval.
"We propose a Bayesian utility approach (BUART) to randomized Phase II clinical trials which uses a first-order bivariate normal dynamic linear model for efficacy and safety in order to determine the optimal dose and study population in a subsequent Phase III clinical trial. "