Carcinogenicity testing of IL-10: principles and practicalities

2002 ◽  
Vol 21 (7) ◽  
pp. 347-358 ◽  
Author(s):  
I Y Rosenblum ◽  
A D Dayan
Keyword(s):  
Immune System ◽  
Critical Evaluation ◽  
Carcinogenic Risk ◽  
Test Results ◽  
Scientific Evaluation ◽  
Regulatory Requirements ◽  
Candidate Drug ◽  
Detailed Evaluation ◽  
Rational Consideration ◽  
Practical Feasibility

IL-10 is a cytokine with actions at many levels of the immune system. In the course of development of recombinant human IL-10 (rhuIL-10) as a potential treatment for a number of chronic diseases of man, the question `What about its carcinogenicity testing?’ was repeatedly asked, based on scientific evaluation by toxicologists, beliefs about regulatory requirements, and questions considered likely to be raised by physicians, patients, and lawyers. The feasibility of various approaches to the carcinogenicity testing of rhuIL-10 is critically discussed here as a contribution to rational consideration of the general need for and value of such testing, and its particular feasibility for a recombinant human protein with profound effects on the immune system. The physiological functions of IL-10 in man and rodents are reviewed in detail, as there are notable differences between species in its normal activities, followed by detailed evaluation of the potential procedures and practical problems of its carcinogenicity testing as a heterologous, immunogenic protein in rodents. The value of information that might be obtained from transgenic mice is also evaluated, and so are the results of studies exploring its actions on human tumour cell biopsies and rodent and human cell lines. It is concluded that despite the probable popular and regulatory expectations that carcinogenicity test results would be provided, all the physiological and pathological information reveals no indication that rhuIL10 would pose a carcinogenic risk to humans on prolonged administration, and that it would not be feasible to undertake such experimentation. It is argued that in this, as in other instances, professional and popular expectations have run beyond practical feasibility or theoretical justification. Cautious and critical evaluation should be made every time shorter or longer term toxicity studies of any candidate drug are planned or even considered, especially if it is a recombinant protein, to decide on objective grounds whether the studies are really necessary and whether they can be done in a way that will give meaningful results that will help in risk assessment.

Development of Some Performance-Based Material Specifications for High-Performance Concrete Pavement

2003 ◽  
Vol 1834 (1) ◽  
pp. 69-76 ◽  
Author(s):  
Prasada Rao Rangaraju
Keyword(s):  
High Performance ◽  
High Performance Concrete ◽  
Concrete Pavement ◽  
Performance Criteria ◽  
Test Results ◽  
Department Of Transportation ◽  
Performance Specifications ◽  
Concrete Materials ◽  
Practical Feasibility

In collaboration with FHWA, the Minnesota Department of Transportation (Mn/DOT) has successfully completed its first experimental high-performance concrete pavement (HPCP) project under the Testing and Evaluation Program (TE-30). This project is one of the 22 projects funded under the TE-30 Program. With a structural design life of 60 years, this HPCP is unique in that it incorporates significant changes to the existing Mn/DOT specifications on concrete materials. Some of the new materials-related specifications developed as a part of this project are based on performance criteria that influence long-term durability of the pavement structure. The background and considerations for selecting the new performance measures are discussed, and test results are presented that evaluate the practical feasibility of establishing and achieving the performance specifications.

Laboratory performance and regulatory requirements.

1987 ◽  
Vol 33 (6) ◽  
pp. 1087-1102 ◽  
Author(s):  
M L Kenney
Keyword(s):  
Linear Regression ◽  
Proficiency Test ◽  
Clinical Laboratory ◽  
Group Practice ◽  
Federal Regulations ◽  
Test Results ◽  
Regulatory Requirements ◽  
Service Levels ◽  
Z Scores ◽  
Log Normal

Abstract We compared performance levels of four clinical laboratory groups defined by federal regulatory characteristics, to assess the appropriateness of selected regulations: laboratories in JCAH-accredited hospitals; non-doctoral-directed independent laboratories; state-regulated but federally exempt group-practice laboratories; and unregulated laboratories in physicians' offices (POLs). Federal regulations evaluated were those dealing with the doctoral directorship requirement and exemption of POLs from regulation. Quantitative analytes were compared by using linear regression on log-normal transformations of mean absolute-z scores of proficiency test results. The scope of services offered by laboratories was statistically related to performance in quantitative analytes. Confounding effects of scope-of-service levels were statistically controlled. Proportions of errors in qualitative analytes were compared. No pattern of statistically discernible differences in performance was found between hospital laboratories and non-doctoral-directed laboratories. Both regulated non-doctoral-directed laboratories and state-regulated but federally exempt group-practice laboratories demonstrated higher levels of performance than unregulated POLs.

scholarly journals Using a Participatory Learning and Action Approach to Improve Young Papuans and Moluccans’ Knowledge of Herbal Drinks to Increase Immunity During the COVID-19 Pandemic

2021 ◽  
Vol 5 (2) ◽  
pp. 297-311
Author(s):  
Rully Adi Nugroho ◽  
Sri Kasmiyati ◽  
Elizabeth Betty Elok Kristiani ◽  
Vincentia Irene Meitiniarti ◽  
Agna Sulis Krave
Keyword(s):  
Immune System ◽  
Medicinal Plants ◽  
Human Population ◽  
Young Generation ◽  
Test Results ◽  
Participatory Learning ◽  
Organoleptic Test ◽  
Participatory Learning And Action ◽  
Novel Virus ◽  
Butterfly Pea

The introduction of coronavirus disease (COVID-19) into the human population represents a tremendous medical and economical crisis. The immune system plays a central role in protecting against this novel virus. This activity aimed to empower young generation using participatory learning and action approach to improve their knowledge about medicinal plants that grow in Indonesia and whose anti-inflammatory, antioxidant, immunomodulatory, and antiviral properties. Organoleptic test results showed that Kunyit Asam (consisted of turmeric and ginger) and Tealang (consisted of butterfly pea and lemongrass) were highly favored by panelists. Our results provide valuable information on the medicinal plants used as an immunity booster within the studied community.

scholarly journals Critical Evaluation for Grading and Fineness Modulus of Concrete Sands used in Sulaymaniyah City-Iraq

2021 ◽  
Vol 27 (10) ◽  
pp. 34-49
Author(s):  
Muhammad Arf Muhammad ◽  
Bilal K. Mohammed ◽  
Faris R. Ahmed ◽  
Bayan S. Al Numan
Keyword(s):  
Critical Evaluation ◽  
Sieve Analysis ◽  
Fine Aggregate ◽  
Size Distributions ◽  
Test Results ◽  
Particle Size Distributions ◽  
Fine Aggregates ◽  
Blending Method ◽  
Field Samples ◽  
Fineness Modulus

Fine aggregates used for concrete works in Sulaymaniyah city frequently fail to meet the standard requirements for gradation and fineness modulus in cement concrete. This paper aims to critically evaluate gradation, fineness modulus, and clay contents of various natural sands produced and used for concrete work in the region.  Sixteen field sand samples were collected from various sites in Darbandikhan (5 samples), Qalat Dizah (5 samples), Koysinjaq (5 samples), and Piramagroon (1 sample) confirming to ASTM D75. The field samples were parted into test specimens based on ASTM C702. Then, sieve analysis was carried out on the oven-dry test specimens in compliance with ASTM C136. The test results of fine aggregates were compared with American, British, and Iraqi specification standards using ASTM C33, BS 882, and IQS No. 45. It was revealed that only three sands satisfy the ASTM gradation limits while others do not comply and are on the coarser side. Also, eight samples meet the requirements recommended by BS 882, whereas five samples meet limits by IQS No. 45. It was found that only three sands have the fineness modulus within the ranges recommended by ACI 211.1 and ACI 211.4, while the others have high values. Furthermore, it was found that all sands include an allowable amount of finer particles passing sieve size 0.075 mm. In order to improve particle size distributions, it is recommended to use the blending method to obtain a suitable fine aggregate from two or more failed sands.

The test results of graduates transport universities for knowledge of regulatory requirements documents on the safety of movement of trains

2020 ◽  
pp. 15-22
Author(s):  
N.O. Berestok ◽  
◽  
V.A. Kobzev ◽  
E.A. Ovchinnikova ◽  
S.P. Shumsky ◽  
...  
Keyword(s):  
Test Results ◽  
Regulatory Requirements ◽  
Requirements Documents

Conducting a comparison of violations committed by employees of the movement economy and errors made during testing for knowledge of PTE.

scholarly journals Assessing the Quality of Glucose Monitor Studies: A Critical Evaluation of Published Reports

2007 ◽  
Vol 53 (6) ◽  
pp. 1122-1128 ◽  
Author(s):  
John Mahoney ◽  
John Ellison
Keyword(s):  
Average Rate ◽  
Critical Evaluation ◽  
Glucose Monitoring ◽  
Reporting Quality ◽  
Performance Evaluations ◽  
Test Results ◽  
Inclusion Criteria ◽  
Future Studies ◽  
Pubmed Database

Abstract Background: In recent years, a large number of studies have been published on the performance of glucose monitors. The quality of these reports is not known. Methods: We searched the PubMed database for performance evaluations of handheld glucose monitors published from August 2002 to November 2006. Relevant articles were compared to 20 recommendations from the Standards for Reporting Diagnostic Accuracy (STARD) and 18 recommendations from the Clinical and Laboratory Standards Institute (CLSI). Results: A total of 52 reports met our inclusion criteria and were reviewed. None (0%) of the reports conformed to all 38 STARD and CLSI recommendations. The range of compliance to these recommendations varied widely (median 53%; range 21%–84%). Only 1 study of the 52 reported following a CLSI recommendation for checking reference test results. Fewer than half (42%) of the reports contained STARD-recommended statements regarding how and when comparative measurements were performed. Conclusions: None of the glucose monitor reports from our review conformed to all STARD and CLSI recommendations. Our finding that the average rate of compliance to recommendations was low suggests that many of the researchers did not follow published recommendations for study design, methodology, and reporting and that study quality and conclusions may have been affected. Future studies evaluating the performance of glucose monitoring systems should be carefully designed and follow published recommendations for methodological and reporting quality.

Nonlinear Contact Analysis of Different API Line Pipe Coupling Modifications

2010 ◽  
Vol 132 (5) ◽  
Author(s):  
Jeroen Van Wittenberghe ◽  
Patrick De Baets ◽  
Wim De Waele
Keyword(s):  
Finite Element ◽  
Critical Evaluation ◽  
Element Model ◽  
Test Results ◽  
Line Pipe ◽  
Bending Fatigue ◽  
Four Point Bending ◽  
Pipe Coupling ◽  
The Finite Element Model ◽  
Good Agreement

Threaded pipe couplings are used to join pipelines when they have to be uncoupled frequently or as an easy to assemble alternative to welding. A large variety of patented coupling modifications are available, but little is known about their influence on the connection’s behavior. In this study, the finite element model of an API line pipe threaded pipe connection is presented and its nonlinearities in material properties and contact behavior are discussed. Test results obtained from a four-point bending fatigue experiment are in good agreement with the results of the numerical simulations. A series of modifications of the standard connection are simulated to gain a better understanding in the influence of geometrical and material parameters on the connection’s performance. It was found that not all existing coupling modifications are improving the connection’s performance. It can be concluded that critical evaluation of the performance of existing coupling modifications is necessary and finite element analyses are proven to be a useful tool for this.

scholarly journals HUBUNGAN TINGKAT STRES DENGAN PENURUNAN SISTEM IMUN PADA MAHASISWA TINGKAT IIA AKADEMI KEPERAWATAN PANTI KOSALA SURAKARTA

2015 ◽  
Vol 3 (1) ◽  
Author(s):  
Ditya Yankusuma Setiani ◽  
Anisa Heni Purwanti ◽  
Nia Asmarani
Keyword(s):  
Immune System ◽  
Data Retrieval ◽  
Mild Stress ◽  
Test Results ◽  
Chi Square ◽  
Stress Levels ◽  
Chi Square Test ◽  
Relationship Stress ◽  
The Relationship

ABSTRACTIntroduction: This study was stress is the body’s response is not specific to any load and demands. Based on observations in the Academy of Nursing Panti Kosala Surakarta especially in level IIA, the authors conducted research at random to ask direct. Most of them complained of stress and dizziness since the coursework overload and besides asking also carried out objectively the data retrieval with observations. From observations made, there are approximately 10 students from 43 students experiencing symptoms such as anxious, tense and not accept lessons concentration and 4 of them have often complained of pain during a lecture.The purpose of the research: Was to find out the relationship stress levels with decreased immune system on student level IIA Academy of Nursing Panti Kosala Surakarta.The Subject of research: Is the entire student level IIA Academy of Nursing Panti Kosala Surakarta amounted to 43 people. The technique used is the saturated samples. Saturated samples is a way of sampling by taking all members of the population to be sampled.The result of the research: Was the number of respondents who experienced mild stress levels of 23 respondents (53,5%) and respondents who experienced a decline in the immune system when it is being stressed that by 30 respondents (69,8%). From the Chi Square test results with the program SPSS version 18.0 with α = 5% (0,05) acquired p of 0,024. The value of less than 0,05 Ha accepted meaning and Ho is rejected.Conclusion of the research: Was the existence of relationship stress levels with decreased immune system on student level IIA Academy of Nursing Panti Kosala Surakarta.Keywords: Stress Levels, Decreased Immune System

The Analysis of Complications of Tuberculosis Sufferers Due to History of Drug Breakup in The Area of Puskesmas Puri Mojokerto Regency

2021 ◽  
Vol 8 (2) ◽  
pp. 166-170
Author(s):  
Lutfi Wahyuni ◽  
Inna Octavia ◽  
Norma Cindy Erlina
Keyword(s):  
Immune System ◽  
Infectious Diseases ◽  
Nutritional Status ◽  
Treatment Period ◽  
Early Stage ◽  
Sampling Technique ◽  
Patient Treatment ◽  
Test Results ◽  
Pulmonary Tb ◽  
History Of

Pulmonary TB disease is one of the priorities of eradication of infectious diseases. Early-stage drug breakup occurs if the patient does not take medication 2 months in a row or more before the treatment period is complete. Drug breakups result in patients being resistant to OAT (Anti-Tuberculosis Drugs) and can lead to complications. This study aimed to analyze the occurrence of complications of tuberculosis sufferers due to a history of drug breakup. The design in this study was Correlation Analytics with Retrospective approach methods. The population in this study was all TB sufferers who had a history of drug breakups and complications. The sampling technique in this study was Non-Probability Sampling with purposive sampling type. The sample was 30 respondents. The instruments were interview for the history of drug breakup and patient treatment cards and observation and status of patient as the instruments of complications. Spearman Rho test results showed that value = 0.055 or more than α (0.05) which meant there was no correlation between the history of drug breakup with complications of tuberculosis. Based on this study, it could be concluded that the complications of tuberculosis that occur not only because of drug breakup factors but can be due to the spread of increasingly widespread germ infections, the immune system of the sufferers who are lacking, tuberculosis concomitant diseases, nutritional status of tuberculosis sufferers, and also knowledge from TB sufferers who lack the awareness to maintain health.

Soot Wear in Diesel Engines

2006 ◽  
Vol 220 (5) ◽  
pp. 463-469 ◽  
Author(s):  
E. S. Yamaguchi ◽  
M Untermann ◽  
S. H. Roby ◽  
P. R. Ryason ◽  
S. W. Yeh
Keyword(s):  
Photoelectron Spectroscopy ◽  
Sliding Wear ◽  
Wear Test ◽  
Test Results ◽  
Regulatory Requirements ◽  
Low Wear ◽  
Stribeck Curves ◽  
Gas Recirculation ◽  
Lubrication Conditions ◽  
Ball On Disc

In response to regulatory requirements, lubricant manufacturers are seeking oils that minimize soot thickening and the accompanying soot wear. Formulation technology is being developed by additive manufacturers to satisfy these requirements. For example, such work is in progress at Chevron Oronite Company LLC, using the Cummins M-11 exhaust gas recirculation (EGR) engine test as a surrogate for the anticipated soot wear test for PC-10. Simultaneously, the authors developed bench tests to screen candidate formulations and reduce costs. A ball-on-disc sliding wear test, using a PCS Instruments MTM® tribometer, has been investigated. Sliding conditions at high pressure are required for soot polishing wear. Conditions that correlate tribometer test results with M-11 engine results at high soot concentrations (∼9 per cent) have been found. Both ball wear and Stribeck curves were determined in these tests. The high-wear oil progresses from mixed lubrication conditions to boundary lubrication at higher sliding speeds than the low-wear oil. X-ray photoelectron spectroscopy experiments were also conducted on the ball wear scars, revealing differences in the chemical constitution of the tribofilms from the two oils.

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