Medical Ultrasound Imaging
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Definity®
www.definityimaging.com/newsroom/newsroom/factsheet.asp From Lantheus Medical Imaging.
Activated DEFINITY® Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. The perflutren lipid microspheres exhibit lower acoustic impedance than blood and enhance the intrinsic backscatter of blood.
Echocardiography with Definity produced more detailed images of the heart in difficult-to-image patients versus echocardiography alone, and images obtained with the contrast agent provided a more accurate assessment of segmental wall motion compared with unenhanced images.

See also Coherent Contrast Imaging.

In August 2001 DuPont Pharmaceuticals Company received FDA approval.

Drug Information and Specification
RESEARCH NAME
DMP 115, MRX 115
INDICATION -
DEVELOPMENT STAGE
APPLICATION
Intravenous
Lipids:DPPA, DPPC,MPEG5000 DPPE
CHARGE
Negative
Octafluoropropane
MICROBUBBLE SIZE
98% < 10μm
PRESENTATION
Package contains four 2mL clear glass single-use vials.
STORAGE
Refrigerate 2−8 °C
PREPARATION
Activate through Vialmix agitation
DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE
NOT A SUBSTITUTE FOR THE ACCOMPANYING PACKAGE INSERT!
Distribution Information
TERRITORY
DISTRIBUTOR
North America, Australia, South Asia, Middle East
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View NEWS results for 'Definity®' (1).Open this link in a new window.
Digital Imaging and Communications in Medicine
(DICOM) DICOM is the industry standard for transferral of radiologic images and other medical information between computers. Patterned after the Open System Interconnection of the International Standards Organization, DICOM enables digital communication between diagnostic and therapeutic equipment and systems from various manufacturers.
The DICOM 3.0 standard evolved from versions 1.0 (1985) and 2.0 (1988) of a standard developed by the American College of Radiology (ACR) and National Electrical Manufacturers Association (NEMA). To support the implementation and demonstration of DICOM 3.0, the RSNA Electronic Communications Committee began to work with the ACR-NEMA MedPacs ad hoc section in 1992.
Also Picture Archiving and Communication Systems (PACS), which are connected with the Radiology Information System (RIS), use commonly the DICOM standard for the transfer and storage of medical images.

See also Digitization.
Disk Storage
The processed data and/or images can be stored on disk. The disks can be a hard disk (HDD), floppy disk (FDD), compact disc (CD) or digital video discs (DVD). Typically, the ultrasound scans are stored and archived with the patient's medical records.

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, Food and Drug Administration, and European Medicines Agency.
EchoGen®
EchoGen® is a fluorocarbon-based (dodecafluoropentane) third generation USCA. EchoGen® consists of microbubbles stabilized with surfactants in a phase shift colloid emulsion (perflenapent). EchoGen® requires no preparation, reconstitution, or refrigeration.
Perflenapent emulsion would represent a significant advance in contrast echocardiography caused by effective and long lasting opacification of the left ventricle and enhanced endocardial border delineation.
The persistence of the contrast effect permits interrogation in multiple echocardiographic views, as well as the visualization and localization of myocardial perfusion deficits at rest by producing a negative contrast effect.
October 12, 2000
Sonus Pharmaceuticals, Inc. announced a strategic decision to refocus the Company on the development of its drug delivery and blood substitute products. At the same time, Sonus has withdrawn the NDA (New Drug Application) and discontinued clinical activity for its ultrasound contrast product, EchoGen®.
August 06, 2001
Sonus Pharmaceuticals, Inc. announced that it has entered into an agreement to sell its ultrasound contrast assets for $6.5 million to Amersham plc. As part of the agreement, Sonus has also assigned to Nycomed its interest in the ultrasound contrast patent license agreement entered into with Chugai Pharmaceutical Co. Ltd. and Molecular Biosystems Inc in January 2001.
Drug Information and Specification
RESEARCH NAME
QW3600
INDICATION -
DEVELOPMENT STAGE
APPLICATION
Intravenous
TYPE
Microbubble
-
CHARGE
Negative
Dodecafluoropentane
MICROBUBBLE SIZE
-
PRESENTATION
-
STORAGE
Refrigerate 2−8 °C
PREPARATION
Finished product
DO NOT RELY ON THE INFORMATION PROVIDED HERE, THEY ARE
NOT A SUBSTITUTE FOR THE ACCOMPANYING PACKAGE INSERT!
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 [last update: 2023-11-06 01:42:00]