The objective of the trial is to determine an optimal dose
for a long-acting implant, as well as safety, compliance and efficacy.
Arroyo suggested that if and when topiramate began to be used as monotherapy, the optimal dose
would be about 100 mg/day.
FDA's Ellen Cooper, who is in charge ofthe AZT application, told members of the committee at its open hearings that, compared with people in the control group, people receiving the drug showed a "highly significant difference in mortality and time until first infection." But, she added, more toxicologic testing on animals is needed, the optimal dose
for humans still is not clear, and more human data are needed.
The phase 1 objectives will include evaluating the overall safety and optimal dose
of YE-NEO-001 and a recommended phase 2 dose.
After the optimal dose
has been determined, the company expects to enrol an expansion cohort of around 40 patients.
One group received their optimal dose
of Vyvanse the first week and placebo the second week.
The currently recommended 20 mg/day dose of lisinopril is based on the drug's blood pressure-lowering effect; the optimal dose
for renoprotection has not been established, said Dr.
When tissue plasminogen activator (TPA) is administered for treatment of an acute ischemic stroke, the dose used for catheter-directed intraarterial fibrinolysis might be inadvertently 100-1,000 times the optimal dose
BERLIN - For atypical antipsychotic drugs, which are still relative newcomers to the psychotropic arsenal, questions of optimal dose
remain unsettled, according to a reanalysis of two pivotal trials reported in a poster presentation at the Seventh World Congress of Biological Psychiatry.
So that basically means that 30% more patients can use the full dose, the optimal dose
The dose-escalation phase of the study determined the optimal dose
of cabozantinib as 40 mg daily when given in combination with atezolizumab (1200 mg infusion once every 3 weeks).
The company stated the T-Force GOLD study is a multicenter, randomised, double-blind, placebo-controlled, parallel group, Phase IIb study to evaluate the safety, tolerability, efficacy and optimal dose
of once-daily INGREZZA (valbenazine) in up to 120 pediatric patients with moderate to severe Tourette syndrome.