scholarly journals Influence of Study Design Variables on Clinical Pathology Data

2016 ◽  
Vol 45 (2) ◽  
pp. 288-295 ◽  
Author(s):  
Adam Aulbach ◽  
Anne Provencher ◽  
Niraj Tripathi

A number of factors related to study design have the potential to impact clinical pathology test results during the conduct of nonclinical safety studies. A thorough understanding of these factors is paramount in drawing accurate conclusions from clinical pathology data generated during such studies, particularly when attempting to make the distinction between test article and nontest article–related effects. Study design and conduct variables with potential to impact clinical pathology data discussed in this overview include those related to species and test system, animal age, animal care and husbandry practices, fasting, acclimatization periods, effects of transportation and stressors, route of administration, effects of in-life and surgical procedures, influence of study length, timing of blood collections, impact of vehicle/formulation composition, and some general concepts related to drug class. The material presented here is a summary based on information presented at the 35th Annual Symposium of the Society of Toxicologic Pathology (June 2016), during Symposium Session 2 titled “Deciphering Sources of Variability in Clinical Pathology—It’s Not Just about the Numbers.”

2003 ◽  
Vol 31 (1_suppl) ◽  
pp. 6-10 ◽  
Author(s):  
Robert L. Hall ◽  
Nancy E. Everds

Interpreting canine and nonhuman primate clinical pathology data from preclinical studies can be challenging. Relatively few animals are tested (typically beagles and macaques), and they often undergo study-related procedures (eg, sample collection for pharmacokinetic analysis) that can affect clinical pathology test results. Data interpretation requires an understanding of the significance of each test, species differences for each test, normal interanimal and intraanimal variability, the effects of study design variables, and supporting data from other disciplines. Interpretation of hematology, coagulation, clinical chemistry, and urinalysis parameters are discussed, with emphasis on species peculiarities and study design variables that may affect clinical pathology test results.


2016 ◽  
Vol 45 (2) ◽  
pp. 362-365 ◽  
Author(s):  
Robert L. Hall

Although interpretation and description of clinical pathology test results for any preclinical safety assessment study should employ a consistent standard approach, companies differ regarding that approach and the appearance of the end product. Some rely heavily on statistical analysis, others do not. Some believe reference intervals are important, most do not. Some prefer severity of effects be described by percentage differences from, or multiples of, baseline or control, others prefer only word modifiers. Some expect a definitive decision for every potential effect, others accept uncertainty. This commentary addresses these differences and underscores the need for flexibility in a “consistent standard approach” because the conditions of every study are unique. This article constitutes an overview of material originally presented at Session 2 of the 2016 Society of Toxicologic Pathology Annual Symposium.


2016 ◽  
Vol 45 (1) ◽  
pp. 90-93 ◽  
Author(s):  
Niraj K. Tripathi ◽  
Nancy E. Everds ◽  
A. Eric Schultze ◽  
Armando R. Irizarry ◽  
Robert L. Hall ◽  
...  

The objectives of this session were to explore causes of variability in clinical pathology data due to preanalytical and analytical variables as well as study design and other procedures that occur in toxicity testing studies. The presenters highlighted challenges associated with such variability in differentiating test article–related effects from the effects of experimental procedures and its impact on overall data interpretation. These presentations focused on preanalytical and analytical variables and study design–related factors and their influence on clinical pathology data, and the importance of various factors that influence data interpretation including statistical analysis and reference intervals. Overall, these presentations touched upon potential effect of many variables on clinical pathology parameters, including animal physiology, sample collection process, specimen handling and analysis, study design, and some discussion points on how to manage those variables to ensure accurate interpretation of clinical pathology data in toxicity studies. This article is a brief synopsis of presentations given in a session entitled “Deciphering Sources of Variability in Clinical Pathology—It’s Not Just about the Numbers” that occurred at the 35th Annual Symposium of the Society of Toxicologic Pathology in San Diego, California.


2021 ◽  
pp. 1-11
Author(s):  
Liu Narengerile ◽  
Li Di ◽  

At present, the college English testing system has become an indispensable system in many universities. However, the English test system is not highly humanized due to problems such as unreasonable framework structure. This paper combines data mining technology to build a college English test framework. The college English test system software based on data mining mainly realizes the computer program to automatically generate test papers, set the test time to automatically judge the test takers’ test results, and give out results on the spot. The test takers log in to complete the test through the test system software. The examination system software solves the functions of printing test papers, arranging invigilation classrooms, invigilating teachers, invigilating process, collecting test papers, scoring and analyzing test papers in traditional examinations. Finally, this paper analyzes the performance of this paper through experimental research. The research results show that the system constructed in this paper has certain practical effects.


2014 ◽  
Vol 496-500 ◽  
pp. 1176-1179
Author(s):  
Li Tan ◽  
Yu Fang

LTX-77 test system is a large IC test system that is used for various kinds of analog IC, digital IC and analog digital mixed IC. It can be used to test DC parameters, AC parameters and logic functions. In the paper, the IC test platform is LTX-77 test system. IC ADC0804 was tested as the test object. The test method of IC is described in the view of actual test. The test results show that the test system is convenient and accurate, which has important practical value for IC manufacturers and users.


2021 ◽  
Author(s):  
Arjen Koop ◽  
Pierre Crepier ◽  
Sebastien Loubeyre ◽  
Corentin Dobral ◽  
Kai Yu ◽  
...  

Abstract Estimates for roll damping are important input parameters for simulation studies on vessels operating at sea, e.g. FPSO mooring in waves, wind and current, workability and operability investigations, Dynamic Position studies, ship-to-ship operations and safety studies of vessels. To accurately predict the motions of vessels this quantity should be determined with confidence in the values. Traditionally, model experiments in water basins using so-called decay tests are carried out to determine the roll damping. With recent advancements in CFD modelling, the offshore industry has started using CFD as an alternative tool to compute the roll damping of FPSO’s. In order to help adopt CFD as a widely accepted tool, there is a need to develop confidence in CFD predictions. Therefore, a practical CFD modelling practice is developed within the Reproducible CFD JIP for roll decay CFD simulations. The Modelling Practice describes the geometry modelling, computational mesh, model set-up and post-processing for these type of CFD calculations. This modelling practice is verified and validated by three independent verifiers against available model test data. This paper provides an overview of the developed modelling practice and the calculated CFD results from the verifiers. The CFD modelling practice is benchmarked against available model test results for a tanker-shaped FPSO. By following this modelling practice, the CFD predictions for the equivalent linear damping coefficient and natural period of the roll motions are within 10% for all verifiers and within 10% from the model test results. Therefore, we conclude that when following the developed modelling practice for roll decay simulations, reliable, accurate and reproducible results can be obtained for the roll damping of tanker-shaped FPSOs.


2021 ◽  
pp. 019262332110413
Author(s):  
Anne Provencher ◽  
Paula Katavolos

This symposium synopsis summarizes key points discussed related to clinical pathology data interpretation for reproduction and juvenile toxicology studies. In pregnant and growing animals, several changes in clinical pathology parameters linked to growth/maturation of organ and physiological functions can occur, and understanding these changes is important to enable accurate interpretation of clinical pathology data. A brief overview of the general approach to clinical pathology data analysis according to contemporary practices is provided, followed by a discussion focused specifically on reproductive and juvenile clinical pathology. In this context, the approach to recognize and differentiate changes that may be related to pregnancy and growth as opposed to those that may be related to test article effects is highlighted.


2013 ◽  
Vol 275-277 ◽  
pp. 1911-1914 ◽  
Author(s):  
Han Jun Hu ◽  
Hui Zhou ◽  
Yu Gang Zheng ◽  
Kai Feng Zhang ◽  
Zhi Hua Wan

The bonded MoS2 films are widely used as solid lubricants in aerospace mechanisms due to their excellent tribological properties. Traditionally, the MoS2 was directly bonded on the Al substrate that was only treated by the technique named of sandblast. For improving the tribological properties of MoS2 films, micro arc oxidation (MAO) instead of sandblast was introduced as a new technique for treating of Al substrate. In this article, the tribological properties of MoS2 films which were bonded on different surface of Al substrate as mentioned above were discussed, respectively. It was concluded from the test results that the MoS2 films bonded on substrate treated by MAO have better tribological properties than those samples treated by sandblast. The endurance life against abrasion of the former is as high as twenty times of the latter by the stand test method of ball on disk using the UMT Multi-Specimen Test System. This test results could be illustrated by the following reasons. The first is the porous microstructures of MAO ceramic coatings on the Al substrate. The coatings have numerous pits to be good at increasing the binding force with the MoS2 films, and the pits can also provide a MoS2 lubricants reservoir during processes of friction. Both of them improved the MoS2 film’s ability of wear-protective. The second is that hardness of the coating is higher than the Al, and this ensures well wearing resistance, especially in practical application to big load-supporting moving parts, such as bearing, gear, etc…


AIHAJ ◽  
1979 ◽  
Vol 40 (10) ◽  
pp. 883-887
Author(s):  
G. P. BEAUMONT ◽  
C. H. GARRIDO
Keyword(s):  

2011 ◽  
Vol 138-139 ◽  
pp. 962-966 ◽  
Author(s):  
Kai Liu ◽  
Li Xu

Experimental study on combustor outlet temperature field of heavy-duty gas turbine had been finished on high-pressure test system. Experimental results indicate: The OTDF is sensitive to diameter of dilution holes, and the RTDF is sensitive to location of dilution holes. The test results have important guiding significance and reference value to design, commission and working about the similar combustor.


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