Assessment of Analytical Method Performance Characteristics : Systematic Error

1977 ◽  
Vol 60 (4) ◽  
pp. 940-945
Author(s):  
Thomas J Dols ◽  
Bernard H Armbrecht

Abstract A random review of the analytical literature shows the need to define more clearly the terms for techniques that are used to assess the merits of analytical methods for a particular purpose. One such performance characteristic is the systematic error or bias of a method. This term is defined and contrasted with other terms commonly used in method assessment. Components of the systematic error are described and techniques are given for their measurement.

2012 ◽  
Vol 5 (1) ◽  
pp. 3-30 ◽  
Author(s):  
G. Shephard ◽  
F. Berthiller ◽  
P. Burdaspal ◽  
C. Crews ◽  
M. Jonker ◽  
...  

This review highlights developments in mycotoxin analysis and sampling over a period between mid-2010 and mid-2011. It covers the major mycotoxins: aflatoxins, Alternaria toxins, ergot alkaloids, fumonisins, ochratoxin, patulin, trichothecenes, and zearalenone. Analytical methods for mycotoxins continue to be developed and published. Despite much interest in immunochemical methods and in the rapid development of LC-MS methodology, more conventional methods, sometimes linked to novel clean-up protocols, have also been the subject of research publications over the above period. Occurrence of mycotoxins falls outside the main focus of this review; however, where relevant to analytical method development, this has been mentioned.


Author(s):  
Punna Venkateshwarlu ◽  
Mehul M. Patel

This article reviews the various analytical methods reported so far in the literature for the determination of stability and impurity profile the lenalidomide and palbociclib anti cancer drugs in single or combination with other drugs in bulk, pharmaceutical dosage forms, biological fluids, stability indicating and impurity profiling methods. The analytical methods used for the estimation of lenalidomide and palbociclib anticancer drugs reviewed in this paper includes ultraviolet spectrophotometry,high performance liquid chromatography (HPLC) ,ultra performance liquid chromatography (UPLC) ,liquid chromatography-mass spectrometry (LC-MS) and electrophoresis. This review focus on the effect of all chromatographic parameters so as to provide as fast, reliable and cost effective methodology of testing. Method development is the process of proving that analytical method is acceptable for use to measure the concentration of active pharmaceutical ingredient in a specific compound dosage form which must be validated to provide reliable data for regulatory submissions. This reviewed is mainly on analytical method development and validation, stability indicating methods, simultaneous estimation methods and bioanalytical methods. The review covers the time period from 2007 to 2019 during which analytical methods including all types of spectrophotometric and chromatographic techniques were reported. The Review covers lenalidomide and palbociclib API and formulation analytical and bioanalytical methods.


2008 ◽  
Vol 1 (3) ◽  
pp. 283-289
Author(s):  
G. Buttinger ◽  
S. Harbeck ◽  
R. Josephs

In the context of control activities contamination of food and feed with aflatoxins is a frequently observed non compliance. Pistachios, peanuts and products thereof are particularly affected. The Institute for Reference Materials and Measurements has therefore produced a peanut butter material certified for its aflatoxin mass fractions. This certified reference material (CRM) allows for the evaluation of analytical method performance and the assessment of the comparability of results from different laboratories. The CRM was produced using naturally contaminated raw materials to ensure equivalent behaviour compared to samples routinely encountered. The homogeneity and stability of the CRM were thoroughly tested and certified values were determined in an inter-laboratory study. Furthermore, uncertainties of the certified values were assessed including contributions of the homogeneity, stability and certification studies to the combined uncertainty. This newly prepared CRM allows an assessment of trueness of the analytical method at a concentration level corresponding to the legal limits enforced in the European Union. The material has the following certified properties: aflatoxin B1 1.77±0.29 µg/kg, aflatoxin B2 0.48±0.07 µg/kg, aflatoxin G1 0.9±0.4 µg/kg, aflatoxin G2 0.31±0.12 µg/kg and total aflatoxins, as sum of aflatoxins B1, B2, G1 and G2, 3.5±0.5 µg/kg.


1997 ◽  
Vol 16 (7) ◽  
pp. 381-385 ◽  
Author(s):  
A.M.García Campaña ◽  
L.Cuadros Rodríguez ◽  
F.Alés Barrero ◽  
M.Román Ceba ◽  
J.L.Sierra Fernández

Author(s):  
Yumiko Takayama ◽  
Hiroyoshi Watanabe

In most cases of high specific speed mixed-flow pump applications, it is necessary to satisfy more than one performance characteristic such as deign point efficiency, shut-off power/head and non-stall characteristic (no positive slope in flow-head curve). However, it is known that these performance characteristics are in relation of trade-offs. As a result, it is difficult to optimize these performance characteristics by conventional way such as trial and error approach by modifying geometrical parameters. This paper presents the results of the multi-objective optimization strategy of mixed-flow pump design by means of three dimensional inverse design approach, Computational Fluid Dynamics (CFD), Design of Experiments (DoE), response surface model (RSM) and Multi Objective Genetic Algorism (MOGA). The parameters to control blade loading distributions and meridional geometries for impeller and diffuser blades in inverse design were chosen as design variables of the optimization process. Pump efficiency, maximum slope in flow-head curve and shut-off power/head were selected as objective functions. Objective functions of pumps, designed by design variables specified in DoE, were evaluated by using CFD. Then, trade-off relations between objective functions were analyzed by using Pareto fronts obtained by MOGA. Some pumps which have specific performance characteristic (non-stall, low shut-off power, high efficiency etc.) designed along the Pareto front were numerically evaluated.


2009 ◽  
Vol 2 (2) ◽  
pp. 34 ◽  
Author(s):  
Marco Aurélio Carino Bouzada

The objective of this paper is to establish a dichotomy - opposing analytical methods (such as Queue Theory) to experimental methods (such as Simulation) and discussing their adequateness to complex operations - set up in the matter of dimensioning the handling capacity of a large brazilian call centers company. The literature related to the application of such methods at call centers is reviewed, and the way the question is treated nowadays by the company is described. Then an experimental approach is suggested to be implemented as an alternative methodology to deal with the issue, instead of the analytical method in use. The results obtained are used to justify the adequacy of the experimental approach to the modern call centers operation, as long as it is possible to have the model closer to reality. The main implication points to a better understanding of the operation achieved with the new approach


Bioanalysis ◽  
2021 ◽  
Author(s):  
Yoshiaki Ohtsu ◽  
Seiji Tanaka ◽  
Harue Igarashi ◽  
Masaaki Kakehi ◽  
Tamiki Mori ◽  
...  

Biomarkers are an important drug developmental tool. Assessment of quantitative analytical methods of biomarkers is not included in any regulatory documents in Japan. Use of biomarkers in clinical evaluations and supporting the post-marketing evaluation of drug efficacy and/or adverse reactions requires assessment and full validation of analytical methods for these biomarkers. The Biomarker Analytical Method Validation Study Group is a research group in Japan comprising industry and regulatory experts. Group members discussed and prepared this ‘points to consider document’ covering measurements of endogenous metabolites/peptides/proteins by ligand binding assays and chromatographic methods with or without mass spectrometry. We hope this document contributes to the global harmonization of biomarker assay validation.


2021 ◽  
pp. arabic cover-english cover
Author(s):  
أحمد المرضي ◽  
محمد النذير الزين

يتناولُ هذا البحثُ التعريفَ بتقنيةِ المعلوماتِ، وماهية الجريمة الإلكترونية، والأخطار الناجمة عنها وتصنيف المُجْرِمين الإلكترونيين، وتنويع الجرائم المُتعلقة بتقنية المعلومات، والأسباب التي تعزي إلى صعوبةِ الكشفِ عنها، وإيراد نموذجًا للجرائم التقنية وفقًا لأحكام القانون الجنائِيّ الإماراتِيّ والمصرِيّ المُتعلقين بمكافحة جرائم تقنية المعلومات. ويشيرُ البحثُ في إيجازٍ إلى: التعريف بالجريمة، وركنها المادي، وبيان شروط الركن المادي، والركن المعنوي، والعقوبة الأصيلة للجريمة، والعقوبة في صورتها المشددة، والعقوبات البديلة. وينطوي البحثُ أيضًا على الأسس الشرعية المُتضمنة حظر الجرائم الماسة بتقنيةِ المعلوماتِ تبعًا لنصوص القرآن الكريم، والسنة النبوية الشريفة، والقواعد الفقهية القاضية بحظر جرائم الانتحال الإلكتروني. ويشتملُ هذا البحثُ على مُقدمةٍ، وخمسة مباحث، وخاتمةٍ على النحو الآتـي: المبحث الأول الأصل الشرعي في تحريم الجرائم الإلكترونية، والمبحث الثاني تعريفات عامة للجرائم المعلوماتية وتصنيفها، والمبحث الثالث أنواع المجرمين المحترفين في المعلوماتية التقنية، وصعوبة اكتشافهم، والمخاطر الأمنية للإنترنت، والمبحث الرابع نماذج من أحكام القانون الجنائي الإماراتي والمصري في مكافحة الجرائم الإلكترونية، والمبحث الخامس الأدلة الرقمية لإثبات الجرائم الإلكترونية وفقًا للقضاءين الإماراتِيّ والمصرِيّ، ثمَّ جاءَت الخاتمةُ لتحتوي على أهم النتائج والتوصياتِ. By this forgoing paper which bearing the title: Combating Electronic Crimes According to Provisions of Criminal Laws of Emirates and Egypt, It Aims to, Enforcement to principals of shariah Law actualization which intents detterence commission crimes through mechanism of” Amr Bil Maroof and Nahy An Munkar”, actualization to the measures of shariah Law that prevent disobedience and electronic crimes. To explain that application of shariah legal maxims such as: "Al Ghurm Bi Al ghunm" whereby it implies whoever owns illegally as a result of committing an offense on a property of whosever should be suffered a penalty, typically to the legal maxim " La dharar wa La dirar ".(damage should be removed) The research methodology which adopted is the descriptive and analytical methods where the researcher intents to define, explains elements and punishments of the crimes. On the other hand the researcher under took the analytical method where he proceeds comparison between the provisions of the two selective criminal laws of Emirates and Egypt, for the achievement the purpose of identification of the similarity and distinctiveness. The problems that presumed to be settled by this research such as: Are there any legal basis to criminalize electronic crime with reference to shariah law? Are there any legal justifications to enforce punishment of fine on the criminal hackers? What are the dangerous consequences for committing the electronic crimes? What are the negative effects for commission electronic crime on individuals and societies at large, and what are the preventive international standards measure and strategies in this context? Concerning the expected achievements by this research, It will enrich the Islamic Library because a comparative research on this topic is so scarce and limited. It will guide the researchers by exploring a new referencing methods for application shariah law, It provides and exposes the legal measure for combating the electronic crimes by using the techniques of detection the electronic criminals by hiding cameras, intelligent phone thumb prints to enable the police investigative officer to deter, identify and arrest the electronic criminals. In the light of combating the researcher advices government officers’ bankers and others to provide top advanced sophisticated technological systems to protect their computers and account numbers against the expected threads of the electronic offences.


2019 ◽  
pp. 1809-1830
Author(s):  
Christophe Othenin-Girard ◽  
Manon G. Guillemette ◽  
Eric Foley ◽  
Claude Caron

Given current economic uncertainties, organizations need to efficiently generate new knowledge and incorporate it into their products and services. In this regard, competitive intelligence provides such strategic knowledge to support the creation of competitive advantages. Part of the knowledge created by competitive intelligence concerns the geographical components forming the basis of geospatial analysis. This study sought to identify, among some 40 competitive analytical methods, those that may be enhanced by geospatial intelligence capabilities. To this end, the authors identified the key subject area of each competitive analytical method and the key spatial analysis operations with geospatial intelligence capability, and then they identified those with a strong potential for providing more strategic knowledge when used in combination. They provide various case scenarios to support their propositions. The results demonstrate that geospatial intelligence may leverage competitive intelligence by more efficiently highlighting business opportunities.


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