The administrative dose guidelines are the predetermined value of radiation dose to workers, below the dose limit (administrative level), which triggers a specific course of action when the dose value is exceeded, or is expected to be exceeded.

See also Medical Internal Radiation Dose Committee, Food and Drug Administration, Material Safety Data Sheet, Annual Dose Limit, Air Kerma, Supervised Area and Drug Development and Approval Process USA.

An anaphylactic reaction is a generalized allergic effect (also called anaphylactic shock). Allergic or anaphylactoid reactions range from sneezing, urticaria and itching, bronchospasm, facial and laryngeal edema to life-threatening symptoms including cardiovascular collapse, shock and respiratory distress.
Iodinated contrast materials are safe and widely used. However, anaphylactoid reactions occur rarely after administration of x-ray contrast agents. Most hypersensitivity symptoms appear short time after the intravenous, oral, rectal or other application (e.g., retrograde pyelography), only few are delayed by hours.
Patients with a history of allergic, asthmatic or reactions to contrast agents are at increased risk of anaphylaxis. Pre-treatment with corticosteroids and antihistamines decreases the incidence of an adverse reaction.

Classification by the Food and Drug Administration (FDA) of medical devices according to potential risks or hazards.

Conray® is a contrast agent intended for intravascular administration as a diagnostic radiopaque medium. Conray® is rapidly transported through the circulatory system to the kidneys and is excreted unchanged in the urine by glomerular filtration.
See also Ionic Contrast Agents, Contrast Media Injector, Dual-Head CT Power Injector, CT Power Injector.

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.