Search results
Results From The WOW.Com Content Network
A Phase IV trial is also known as a postmarketing surveillance trial or drug monitoring trial to assure long-term safety and effectiveness of the drug, vaccine, device or diagnostic test. [1] Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives regulatory approval to be ...
A court order is an official proclamation by a judge (or panel of judges) that defines the legal relationships between the parties to a hearing, a trial, an appeal or other court proceedings. [2] Such ruling requires or authorizes the carrying out of certain steps by one or more parties to a case.
The main goal of a dose-ranging study is to estimate the response vs. dose given, so as to analyze the efficacy and safety of the drug. Although such a response will nevertheless be available from phase III or phase IV trials, it is important to carry out dose-ranging studies in the earlier phase I or phase II stages. There are advantages to ...
The intent of a challenge study is to fast-track the timeline for providing evidence of safety and efficacy of a therapeutic drug or vaccine, especially by compressing (to a few months) the usually lengthy duration of Phase II–III trials (typically, many years). [2] [3] [12] Following preliminary proof of safety and efficacy of a candidate ...
A pivotal trial is typically a Phase III clinical trial in the multi-year process of clinical research intended to demonstrate and confirm the safety and efficacy of a treatment – such as a drug candidate, medical device or clinical diagnostic procedure – and to estimate the incidence of common adverse effects. [1]
A judge may cancel a trial prior to the return of a verdict; legal parlance designates this as a "mistrial". A judge may declare a mistrial due to: The court determining that it lacks jurisdiction over a case. Evidence being admitted improperly, or new evidence that might seriously affect the outcome of the trial being discovered.
The trials are typically conducted in three phases: [5] Phase 1: The drug is tested in 20 to 100 healthy volunteers to determine its safety at low doses. About 70% of candidate drugs advance to Phase 2. Phase 2: The drug is tested for both efficacy and safety in up to several hundred people with the targeted disease.
Michigan law, Mich. Ct. R. 3.211(B)(3) (1998) directs that a judgment of divorce must include a determination of the parties' property rights. The New Jersey Supreme Court, in Frankel v. Frankel, 274 N.J. Super. 585, 644 A.2d 1132 (App. Div. 1994), prohibits bifurcation except in the most unusual and extenuating circumstances. Some states, by ...