Biomedical subjects

Orhan H Suleiman

Publications and source records attributed to Orhan H Suleiman.

3 recordsLinked to original sources

PubMed2006

The radioactive drug research committee: Background and retrospective study of reported research data (1975-2004).

In the United States, human research involving radioactive drugs must be conducted under a Food and Drug Administration (FDA) investigational new drug (IND) application, unless specifically exempt from IND requirements, or under the direct oversight of a Radioactive Drug Research Committee (RDRC) as long as certain conditions are met. Research overseen by RDRCs is considered basic science research when its purpose is to advance scientific knowledge and not to determine a radioactive drug's safety and effectiveness as a therapeutic, diagnostic, or preventive medical product in humans. We retrospectively reviewed and analyzed available study data from annual reports submitted to the FDA dating back to 1976. In 1976, there were 18 studies involving 531 subjects compared with 2003, when there were 284 RDRC studies involving 2,797 subjects. In 1976, RDRC subjects were imaged 5% of the time using positron-emitting nuclides and 77% of the time with conventional gamma-emitting nuclides. In 2003, this was reversed with 77% using positron emitters and 5% using conventional gamma-emitters. In 1976, pediatric studies comprised 7.3% of all RDRC subjects; today pediatric RDRC studies are rarely conducted. Today the RDRC is used primarily by large medical research institutions. Although the program has a very good safety record, RDRC's 30-y-old regulations need to be revised to be consistent with current scientific knowledge and health policy.

Biomedical Research↗

PubMed2005

Reference values for diagnostic radiology: application and impact.

Reference values (RVs) are recommended by the American Association of Physicists in Medicine for four radiographic projections, computed tomography, fluoroscopy, and dental radiography. RVs are used to compare radiation doses from individual pieces of radiographic equipment with doses from similar equipment assessed in national surveys. RVs recommended by the American Association of Physicists in Medicine have been developed from the Nationwide Evaluation of X-ray Trends survey performed by the state radiation protection agencies with the cooperation and support of the U.S. Food and Drug Administration, the Conference of Radiation Control Program Directors, and the American College of Radiology. The RVs selected by the American Association of Physicists in Medicine represent, approximately, the 80th percentile of the survey distributions. Consequently, equipment exceeding the RVs is using higher radiation doses than is 80% of the equipment in the surveys. Radiation doses for specific projections, with standard phantoms, should be measured annually, as recommended by the American College of Radiology. When the RVs are exceeded, the medical physicist should investigate the cause and determine, in cooperation with the responsible radiologist, whether these doses are justified or the imaging system should be optimized to reduce patient radiation doses. RVs are a useful tool for comparing patient radiation doses at institutions throughout the United States and for providing information about radiographic equipment performance.

Equipment Safety↗

PubMed2004

Nationwide Evaluation of X-ray Trends survey of abdomen and lumbosacral spine radiography.

Results of the 1995 Nationwide Evaluation of X-ray Trends (NEXT) survey of facilities that perform diagnostic radiographic examinations of the abdomen and lumbosacral spine were compared with those of previous NEXT surveys conducted in 1987 and 1989. A clinically validated radiographic phantom was used in the 1995 survey to capture data about radiation exposure and image quality. Additional data were obtained regarding clinical techniques, facility workloads, x-ray beam quality, film processing quality, and darkroom fog. Mean skin-entrance air kerma for the abdomen examination dropped from 3.2 mGy (in 1987) to 2.8 mGy at hospitals and from 3.4 mGy (in 1989) to 3.0 mGy at nonhospital facilities. Mean skin-entrance air kerma also decreased for the lumbosacral spine examination from 3.7 mGy (in 1987) to 3.3 mGy at hospitals and from 3.8 mGy (in 1989) to 3.2 mGy at nonhospital facilities. The quality of film processing improved, although 58 (18.3%) of 317 surveyed facilities did not meet the Mammography Quality Standards Act standard for film processing quality, compared with 185 (5.9%) of 3,120 mammography facilities inspected in 1995. Finally, 181 (58.0%) of 312 surveyed facilities had darkroom fog levels greater than the Mammography Quality Standards Act standard, compared with 1,426 (16.6%) of 8,605 mammography facilities inspected in 1995.

Health Care Surveys↗