Radiology - Technology Information Portal
Monday, 29 April 2024
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Dosimetry
Dosimetry is the science or technique of determining a radiation dose.
• View DATABASE results for 'Dosimetry' (6).Open this link in a new window.
Double Contrast
A double contrast exam uses both a radiopaque and a radiolucent contrast agent. Double contrast is for example used in gastrointestinal examinations to show the pattern of mucosal ridges. The walls of the intestine are coated with the radiopaque barium and the lumen is filled with radiolucent air.
Doubling Dose
(DD) The doubling dose is the dose required to double the effect, assuming a linear dose response.
• View DATABASE results for 'Doubling Dose' (2).Open this link in a new window.
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.
Dual-Head CT Power Injector
The industry standard of computed tomography (CT) contrast media power injectors changed over time from single-head to dual-head systems. The advantage of a power (or pressure) injector with two syringes is that a saline solution can be injected first to open the veins, followed by a second injection with contrast agent. Then the first head flushes the saline to maintain contrast flow. As a result, much less contrast agent is needed (about 30 percent less), helping to reduce costs. Dual-head contrast media injectors also provide greater patient safety by reducing the pressure of the flow rate, helping to prevent damage to the veins.
Contrast delivery is much more controlled and efficient when using a dual-head power injector (also called double-piston injector). Also, these medical devices are required to accommodate the quick imaging times typical for a multi-detector CT scanner.

See also Contrast Media Injector, Single-Head CT Power Injector, CT Power Injector, Multi-Head Contrast Media Injector, Syringeless CT Power Injector.
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 [last update: 2023-11-06 02:01:00]