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Searchterm 'Phase' found in 3 terms [
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Cardiac Phase
A particular point in the cardiac cycle.

See also Arrhythmia Rejection.
Multiphase Bone Scintigraphy
A multiphase bone scintigraphy (bone scan) is a nuclear medical examination including blood flow images, immediate images, and delayed images.
The blood flow study is a dynamic sequence of planar images of the bone region of interest obtained during the injection of the radiopharmaceutical (radioactive tracer).
The immediate phase (blood pool or soft tissue study) include one or more static images of selected regions, obtained immediately after the blood flow phase within 10 min.
Delayed images (usually whole body) are usually acquired 2-5 hours after injection. Later (6-24 hour) delayed images result in a higher target to background ratio and may permit better evaluation of the pelvis if this was obscured by bladder activity on the routine images. This late imaging may be particularly helpful in patients with renal insufficiency or peripheral circulatory disorders and those with urinary retention.
Phase 1, 2, 3, 4 Drug Trials
Different stages of testing drugs in humans, from first application in humans through limited and broad clinical tests, to postmarketing studies. Preclinical trials are the testing in animals.
Phase I: Safety, pharmacokinetics
Phase II: Dose
Phase III: Efficacy
Phase IV: Postmarketing
Drug Development and Approval Process (USA)
Different stages of the drug development and approval process in the USA, lead from preclinical trials (testing in animals), first application in humans through limited and broad clinical tests, to postmarketing studies.

Years Test Population Purpose Success Rate
Preclinical Testing 3.5 Laboratory and animal studies Assess safety and biological activity 5,000 compounds evaluated
File IND at FDA
Phase I 1 20 to 80 healthy volunteers Determine safety and dosage 5 enter trials
Phase II 2 100 to 300 patient volunteers Evaluate effectiveness, look for side effects
Phase III 3 1000 to 3000 patient volunteers Verify effectiveness, monitor adverse reactions from long-term use
File NDA at FDA
FDA 2.5 Review process / Approval 1 approved
12 Total
Phase IV Additional Post marketing testing required by FDA

By Dale E. Wierenga, Ph.D. and C. Robert Eaton
Office of Research and Development
Pharmaceutical Manufacturers Association

'In reviewing this report, it is important to keep in mind the realities of the drug discovery and development process. The U.S. system of new drug approvals is perhaps the most rigorous in the world. On average, it costs a company $359 million to get one new medicine from the laboratory to the pharmacist's shelf, according to a February 1993 report by the Congressional Office of Technology Assessment.'

See also Phase 1 2 3 4 Drug Trials, Clinical Trial, Food and Drug Administration, and European Medicines Agency.
Contrast Media Injector
Contrast media injectors are part of the medical equipment used to deliver fluids in examinations such as CT, MRI, fluoroscopy and angiography. Many of these diagnostic imaging procedures include the administration of intravenous contrast agents to enhance the blood and perfusion in tissues.

Mainly there are two types of injector technology:
Piston-based systems use a plunger/piston to move a piston in the cylinder of a reservoir, which works in two directions to first fill the reservoir and then deliver the fluid from the reservoir to the patient, similar to a hand-held syringe.
Peristaltic-pump-based systems operate as rotary pumps that use rollers to compress sections of flexible tubing, drawing fluid directly from the supply source and delivering it to the patient.

See also Single-Head Contrast Media Injector, Dual-Head CT Power Injector, Syringeless CT Power Injector.

The use of x-ray contrast agents in computed tomography (CT) began with a hand injection by the radiologist in the scan room. During its history, CT scanners have made great improvements in speed and image quality. Actual CT systems with multiple detectors allow scan times of a few seconds per body region. Some CT protocols require multiphase scans, where a body region is imaged with a single bolus of contrast in different blood flow phases. Automatic power (pressure) contrast media injectors are required to provide precise control of flow rate, volume and timing of injection. The use of a saline bolus following contrast administration reduces the volume of contrast required.

Most relevant topics for the use of a power injector in medical imaging procedures such as contrast enhanced computed tomography (CECT):
Avoidance of microbiologic contamination;
workflow efficiency in the use of the contrast media injector;
contrast cost and waste volume;
reimbursement.

Must have basic injector control options:
Flow rate with a usual range from 0.1 to 10 mL/sec in 0.1 mL/sec increments; some injectors can be set to inject in ml/min or ml/hour;
volume range from 1 mL to 200 mL for contrast and saline phases;
pressure limit typically programmable from 50 psi to 300 psi in 1 psi increments (also displayable in kPa and kg/cm²).

Examples of other injector control options:
Warmer/heater; an increase in temperature of the contrast medium results in a decrease in its viscosity; warmed contrast media are less viscous and offer lesser resistance;
pre-filled syringes; the compatibility with many selected syringes makes it easy to change and select the appropriate contrast medium for each patient;
injection reports accessible via RIS/PACS for dose management systems and records of prior injections.

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