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At least 19 recordsLinked to original sources
PubMed2004

Canadian Standards Association standard CAN/CSA/Z264.1-02:2002: a new voluntary standard for spacers and holding chambers used with pressurized metered-dose inhalers.

A new Canadian standard (CAN/CSA/Z264.1-02:2002) has been published with the purpose of helping to ensure the safety, efficacy and functionality of spacers and/or holding chambers. They are prescribed for use by spontaneously breathing patients for the treatment of various respiratory diseases where medication is delivered to the lungs using pressurized-metered dose inhalers. This consensus standard was developed with the support of pharmaceutical companies and manufacturers of spacers and holding chambers, and with the help of clinicians, retail pharmacists and representatives of patient advocate bodies associated with respiratory diseases and the dissemination of information related to the treatment and the delivery of inhaled medications. Advice was also sought from expert groups outside of Canada to ensure that the standard would be relevant internationally. Whereas monographs in the pharmaceutical compendia and guidance documents published by regulatory bodies provide information that is largely about the drug product and inhaler, this is the only standard whose focus is primarily on these add-on devices. The purpose of the present review is to highlight the main features of the standard for clinicians by describing its scope, the tests that are intended to assure the robustness of the construction of these devices, the type of testing that is specified to establish in vitro efficacy, and the recommendations for the marking and labelling of the device and its associated packaging. Manufacturers who test their products to this Canadian Standards Association standard will be able to provide performance information about add-on devices to the clinician, facilitating an informed decision when selecting devices for patients.

Adolescent↗
PubMed1978

International standard for anti-Brucella abortus serum: comparison of the complement-fixing activity of the first and second international standards and the EEC standard.

Although the three standards have similar agglutinating activities, it was found that the first International Standard had about half the complement-fixing activity of the second International Standard and the EEC standard. The complement-fixing activities of the latter two standards were similar. On the basis of these results, showing that the agglutination and complement-fixation tests measure different biological activities in anti-Brucella abortus sera, the WHO Expert Committee on Biological Standardization in 1976 assigned separate unitages of agglutinating and complement-fixing activity to the second International Standard for Anti-Brucella abortus Serum.

Agglutination Tests↗
PubMed2005

Establishment of a universal size standard strain for use with the PulseNet standardized pulsed-field gel electrophoresis protocols: converting the national databases to the new size standard.

The PulseNet National Database, established by the Centers for Disease Control and Prevention in 1996, consists of pulsed-field gel electrophoresis (PFGE) patterns obtained from isolates of food-borne pathogens (currently Escherichia coli O157:H7, Salmonella, Shigella, and Listeria) and textual information about the isolates. Electronic images and accompanying text are submitted from over 60 U.S. public health and food regulatory agency laboratories. The PFGE patterns are generated according to highly standardized PFGE protocols. Normalization and accurate comparison of gel images require the use of a well-characterized size standard in at least three lanes of each gel. Originally, a well-characterized strain of each organism was chosen as the reference standard for that particular database. The increasing number of databases, difficulty in identifying an organism-specific standard for each database, the increased range of band sizes generated by the use of additional restriction endonucleases, and the maintenance of many different organism-specific strains encouraged us to search for a more versatile and universal DNA size marker. A Salmonella serotype Braenderup strain (H9812) was chosen as the universal size standard. This strain was subjected to rigorous testing in our laboratories to ensure that it met the desired criteria, including coverage of a wide range of DNA fragment sizes, even distribution of bands, and stability of the PFGE pattern. The strategy used to convert and compare data generated by the new and old reference standards is described.

Databases as Topic↗
PubMed2001

Whose standard is it, anyway? How the tobacco industry determines the International Organization for Standardization (ISO) standards for tobacco and tobacco products.

OBJECTIVE: To describe the extent of the tobacco industry involvement in establishing international standards for tobacco and tobacco products and the industry influence on the International Organization for Standardization (ISO). METHODS: Analysis of tobacco industry documents made public as part of the settlement of the Minnesota Tobacco Trial and the Master Settlement Agreement. Search words included "ISO", "CORESTA", "Barclay", "compensation and machine smoking", "tar and nicotine deliveries", and the name of key players, in different combinations. RESULTS: It is clear that the tobacco industry, through the Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA), play a major role in determining the scientific evidence and suggesting the standards that are eventually adopted as international standards for tobacco and tobacco products in several areas, including the measurement of cigarette tar and nicotine yield. CONCLUSIONS: ISO's tobacco and tobacco products standards are not adequate to guide tobacco products regulatory policies, and no health claims can be made based on ISO's tobacco products standards. There is an urgent need for tobacco control advocates and groups worldwide to be more involved with the work of the ISO, both directly and through their national standardisation organisations.

Consumer Product Safety↗
PubMed1997

Gender- and race-based standards of competence: lower minimum standards but higher ability standards for devalued groups.

Stereotypes may influence judgment via assimilation, such that individual group members are evaluated consistently with stereotypes, or via contrast, such that targets are displaced from the overall group expectation. Two models of judgment--the shifting standards model and status characteristics theory--provide some insight into predicting and interpreting these apparently contradictory effects. In 2 studies involving a simulated applicant-evaluation setting, we predicted and found that participants set lower minimum-competency standards, but higher ability standards, for female than for male and for Black than for White applicants. Thus, although it may be easier for low- than high-status group members to meet (low) standards, these same people must work harder to prove that their performance is ability based.

Female↗
PubMed1990

[National Institute of Hygienic Sciences Standard (the Japanese Pharmacopoeia Standard) "Endotoxin Reference Standard" (Control 891)].

The second "Endotoxin Reference Standard" (Control 891) of the National Hygienic Sciences (Japanese Pharmacopoeia Standard) was prepared. As a result of the test of its potency against the preceding lot of the Reference Standard (Control 881), the second "Endotoxin Reference Standard" (Control 891) containing 16000 endotoxin units per vial was authorized.

Endotoxins↗
PubMed1988

Suggested standards for reports dealing with cerebrovascular disease. Subcommittee on Reporting Standards for Cerebrovascular Disease, Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery/North American Chapter, International Society for Cardiovascular Surgery.

The evaluation of clinical reports on vascular disease is often made difficult by variations in descriptive terms, clinical classification, and outcome criteria. In 1983 the Joint Council of the Society for Vascular Surgery and the North American Chapter of the International Society for Cardiovascular Surgery created the Ad Hoc Committee on Reporting Standards to address these problems and recommend solutions. Some general problems were addressed in the initial report dealing with lower extremity ischemia. This article concerns clinical standards for reports dealing with cerebrovascular disease, suggests a scheme for clinical classification, and recommends standardized reporting practices for grading risk factors, angiographic and other diagnostic findings, and the results and complications of therapeutic intervention.

Cerebrovascular Disorders↗
PubMed1991

Suggested standards for reporting on arterial aneurysms. Subcommittee on Reporting Standards for Arterial Aneurysms, Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery and North American Chapter, International Society for Cardiovascular Surgery.

The literature on arterial aneurysms is subject to potential misinterpretation because of inconsistencies in reporting standards. The joint councils of the Society for Vascular Surgery and the North American Chapter of the International Society for Cardiovascular Surgery appointed an ad hoc committee to address this issue. This communication, prepared in response to the need for standardized reporting, defines and classifies arterial aneurysms and recommends standards for describing the causes, manifestations, treatment, and outcome criteria that are important when publishing data on aneurysmal disease.

Aneurysm↗
PubMed1997

[Studies on the molecular weight standards for size-exclusion chromatography--standardization of a molecular weight standard for water-soluble polymers].

The possibility of the standardization of molecular weight standards for size-exclusion chromatography (SEC) was investigated in the case of water-soluble polysaccharides such as dextran, hyaluronate and chitosan. In the case of dextran, comparing the method adopted for dextran in EP and BP, it was shown that pullulan, one of commercially available molecular weight standards, can be used in usual SEC method. For hyaluronate and chitosan, applying the Mark-Houwink correction to the calibration curve obtained by pullulan, the acceptable molecular weights could be estimated.

Chitin↗
PubMed1982

Standard deviation, standard error. Which 'standard' should we use?

Standard deviation (SD) and standard error (SE) are quietly but extensively used in biomedical publications. These terms and notations are used as descriptive statistics (summarizing numerical data), and they are used as inferential statistics (estimating population parameters from samples). I review the use and misuse of SD and SE in several authoritative medical journals and make suggestions to help clarify the usage and meaning of SD and SE in biomedical reports.

Research↗
PubMed1998

How standard is a standard day during a standard ambulatory 24-hour esophageal pH monitoring?

BACKGROUND: Ambulatory 24-h esophageal pH monitoring is the gold standard method for measuring esophageal exposure to gastric acid. The method has gained acceptability because of its sensitivity, specificity, and accuracy and also because it is easy to perform, well tolerated, and quite physiologic. However, whether ambulatory esophageal pH-metry affects normal lifestyle has not been specifically evaluated. METHODS: We investigated 114 consecutive patients admitted to our Unit because of heartburn, acid regurgitation, or non-cardiac chest pain. Patients filled in a diary chart on 2 different days: 1 day while the pH-metry was performed and another normal day, to record the following variables: number, amount, and composition of the meals; time in supine position; number of cigarettes smoked; alcohol intake; degree of physical activity; and number and type of symptomatic episodes. Patients were encouraged to carry out normal activity. RESULTS: When the 2 days were compared, none of the registered variables appeared to differ, with the exception of subjective evaluation of physical activity: 65% of the patients said their physical activity was diminished during the test day relative to their usual standard. CONCLUSIONS: Normal habits are not significantly modified by 24-h esophageal pH-metry, with the exception of physical activity, which decreases, possibly owing more to aesthetic than to physical problems.

Activities of Daily Living↗
PubMed1996

Maintaining standards: differences between the standard deviation and standard error, and when to use each.

Many people confuse the standard deviation (SD) and the standard error of the mean (SE) and are unsure which, if either, to use in presenting data in graphical or tabular form. The SD is an index of the variability of the original data points and should be reported in all studies. The SE reflects the variability of the mean values, as if the study were repeated a large number of times. By itself, the SE is not particularly useful; however, it is used in constructing 95% and 99% confidence intervals (CIs), which indicate a range of values within which the "true" value lies. The CI shows the reader how accurate the estimates of the population values actually are. If graphs are used, error bars equal to plus and minus 2 SEs (which show the 95% CI) should be drawn around mean values. Both statistical significance testing and CIs are useful because they assist the reader in determining the meaning of the findings.

Confidence Intervals↗
PubMed2006

Standards for plasma and serum proteomics in early cancer detection: a needs assessment report from the national institute of standards and technology--National Cancer Institute Standards, Methods, Assays, Reagents and Technologies Workshop, August 18-19, 2005.

NIST and the National Cancer Institute cosponsored a workshop on August 18-19, 2005, to examine needs for reference materials for early cancer detection. This meeting focused on standards, methods, assays, reagents, and technologies. Needs for plasma and serum proteomics, DNA methylation, and specimen reference collections were discussed, and recommendations from participants were solicited. This report summarizes the discussion and recommendations for proteomics reference materials.

Biomarkers, Tumor↗