Location of topics in NIH guidelines for research involving recombinant DNA molecules.
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This article includes the recommendations submitted by the 15 members of the Oklahoma Attorney General's Task Force in their Report on the State of End-of-Life Health Care. The task force was created on April 21, 2004, and their report was accepted by Attorney General W.A. Drew Edmondson at a press conference April 11, 2005. It has been forwarded to members of the Oklahoma Legislature, relevant state agencies and organizations with an invitation to join with members of the task force to continue efforts to improve end-of-life care for Oklahomans. Copies of the report are available upon request to the Office of Attorney General.
The topics discussed by the Working Group on Toxicity Testing of Chemical Mixtures included the following (1) the study designs and results from two real-life exposure scenarios as additional information to the various investigations reported at the conference; (2) the need to take into consideration low-level, long-term exposure (i.e. mimicking human exposure conditions) as well as the issue of limited resources in experimental toxicology studies; (3) the importance of exploring alternative and predictive toxicology methodologies to minimize animal use and to conserve resources; (4) the realization that interactive toxicity should include the consideration of physical and biological agents in addition to chemicals. Two specific studies reported at the conference were also discussed. A number of recommendations were made concerning the planning and implementation of toxicology studies on chemical mixtures.
Clinical guidelines are a very hot topic. Many guidelines are being published, but many concerns about guidelines still exist. Guidelines may be able to increase the quality of health care while eliminating unnecessary or inappropriate care. Critics wonder if the process will instead lead to poorer care and a waste of time and effort. Although guidelines are targeted on providers of care, those with other roles will use guidelines for optimizing patient care and outcomes, assuring quality, cutting costs and tracking liability and risk management. Examination of guidelines and their impact suggest that the process and product are imperfect and that the impact is difficult to measure. The chiropractic profession will continue in its guideline efforts. The direct effects of guidelines will be on certain aspects of doctor knowledge, attitude, belief and behavior. The indirect effects will be largely attitudinal in nature at first but will eventually lead to action. The profession will embrace the need to (a) develop a more comprehensive and useful research database and (b) to develop sophisticated means for obtaining profession-wide consensus on fundamental clinical issues.
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Photostimulable storage phosphor (PSP) image acquisition systems have been available for several years. The technology has had the opportunity to mature; however, there has not been an independent comparison of recently marketed commercial systems. For this study, three computed radiography (CR) systems using PSP technology (Kodak CR System 400 with autoloader [Eastman Kodak, Rochester, NY], Fuji FCR AC-3CS [Fuji Medical Systems, Stamford, CT], and Agfa ADC Compact [Bayer Corp, Ridgefield Park, NJ]) were connected to an IBM RadWorks diagnostic radiology workstation (IBM Corp, White Plains, NY) and evaluated for conformance to their performance specifications using guidance provided in the most recent draft acceptance testing protocol from Task Group No. 10, American Association of Physicists in Medicine. In addition, the physical requirements (e.g., space and power) and connectivity to another manufacturer's diagnostic workstation were examined. X-ray technologist comfort with each PSP imaging system and an assessment by our supporting biomedical equipment maintenance activity of their ability to service each PSP imaging system were also considered.
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A survey is given of the methods for the determination of the absolute bioavailability for drug substances with long elimination half-lives. All methods depend on the assumption of linear pharmacokinetics. Emphasis is laid on Urso and Aarons' regression method of truncated areas-under-the-curve (AUC) to obtain estimates of the absolute bioavailability, F, and the absorption rate constant, ka, without obeying the otherwise general rule of following blood or plasma levels for at least three times the terminal half-life. It is shown by simulation when the linear and when the logarithmic trapezoidal rule is to be used for the calculation of the AUC. Two PC-programs for the regression method of truncated areas are presented: one program (SIMF&KA.EXE) simulates, based on tentative pharmacokinetic parameters, whether a blood sampling scheme, together with the precision of the analytical assay, is adequate to obtain accurate and precise estimates of F and ka; the method is insensitive to large variations in the tentative value of the elimination half-life. The other program (ESTF&KA.EXE) provides estimates of F and ka, with standard deviations of the estimates, from empirical data.