These experimental designs should better inform next-step radiation-agent clinical trial dose, schedule, exposure, and therapeutic effect.
Design/Method: As part of a previously published, active-control, LTG monotherapy trial, dose and plasma concentration data for LTG, carbamazepine (CBZ) or phenytoin (PHT) were obtained.
For pharmaceuticals, systemic dose data are generated routinely in nonclinical safety studies very early in the toxicity testing program and play a major role in the selection of clinical trial doses.
For all subjects, regardless of outcome or length of trial, dose was not correlated with CYP2D6 or CYP2C19 metabolizer status (see Table 3).
In the phase 2 bapineuzumab trial, dose-related vasogenic edema (ARIA-E) was observed [ 20].
In the trial, dose escalation was given to overcome the loss of clinical efficacy.
We normally take 500 pg mRNA/embryo as a trial dose for injection.
All horses were administered dobutamine during each trial (dose range 0.5-1 μg/kg/min).
This raises other critical issues that need to be addressed before pursuing a future trial: dose and oxidation.
In the Intergroup/CALGB 9741 trial, dose-dense doxorubicin, cyclophosphamide and paclitaxel significantly improved disease-free survival (DFS) compared with conventional dosing [ 2].
