Validation

s The goal of this study was to develop and validate a liquid chromatography (LC) method for the rapid determination of dipyrone (metamizole sodium) in solid and liquid formulations. Samples were extracted with water and filtered prior to LC analysis. The analytical procedure involved reversed phase LC with a Zorbax SB C 18 column (5 m particle size, 4.6 mm × 250 mm i.d.), isoctratic methanol/water (80/20, v/v) mobile phase with UV detection at 254 nm. The flow rate was 1 mL min −1 , injection volume was 100 L and retention time of dipyrone was 3.3 min. The method was validated with respect to linearity, precision and accuracy. Calibration curves were linear in the range 0.5–100 g mL −1 for analyte and the recoveries at three levels (10, 15 and 25 g mL −1) ranged from 93 to 100%. All results for dipyrone were confirmed by liquid chromatography–mass spectrometry (LC–MS) and 1 H nuclear magnetic resonance (NMR) spectroscopy. Due to its simplicity and accuracy, the assay method is suitable for routine analysis of both solid and liquid formulations and seven retail samples were analyzed using the validated method.

Background To assess the psychometric properties, including internal consistency, construct validity, criterion validity, criterion-group validity, and responsiveness, the Reviewed McGill Quality of Life Questionnaire (MQOL-R), into Brazilian Portuguese-(BrP). Also, to analyze the relationship of the BrP-MQOL-R with the scores on the Karnofsky Performance Scale (KPS) and on the Numerical Pain Scale (NPS 0–10). Methods The BrP-MQOL-R was administered to a sample of 146 adults (men = 78). A team of experts translated the MQOL-R according to international guidelines. Convergent validity and Confirmatory factor analysis (CFA) was performed. Results The BrP-MQOL-R Cronbach’s alpha was 0.85. CFA supported the original four-factor structure, with the following revised model fit-indices: PCLOSE = 0.131, Tucker-Lewis Index (TLI) rho 2 = 0.918, incremental fit index (IFI) delta 2 = 0.936. The convergence validity is supported by a significant correlation between BrP-MQOL-R total scores and th...

Bizumic et al. (2013) have recently shown that attitudes towards peace and war reflect two distinct constructs rather than two poles of a single dimension. We present an attempt at validating the French version of their 16-item Attitudes toward Peace and War Scale (APWS) on five distinct (mainly Belgian) French-speaking samples (total N = 808). Confirmatory factor and criterion validity analyses confirmed that attitudes toward peace and war, although negatively related, are distinct in terms of their antecedents and consequences. On the one hand, antecedents of attitudes toward peace included egalitarian ideological beliefs and empathic concern for others, and consequences included intentions to engage in pro-peace behaviors. On the other hand, antecedents of attitudes toward war included national identification and authoritarian ideological beliefs, and consequences included intentions to engage in pro-war behaviors. Furthermore, both attitudes toward peace and war were, respective...

Formal methods have traditionally been used for specification and development of software. However there are potential benefits for the testing stage as well. The panel session associated with this paper explores the usefulness or otherwise of formal methods in various contexts for improving software testing. A number of different possibilities for the use of formal methods are explored and questions raised. The contributors are all members of the UK FORTEST Network on formal methods and testing. Although the authors generally believe that formal methods are useful in aiding the testing process, this paper is intended to provoke discussion. Dissenters are encouraged to put their views to the panel or individually to the authors.

We describe a simple method to validate data collected from a study using the deuterium oxide dose-to-the-mother technique for breastfeeding evaluation. We used human milk intake calculation spreadsheets (n=180). The calculation was performed by fitting the deuterium enrichment data to a model for water turnover in the mother and in the baby. We assumed that the validity of the results is as high as the square root mean square error (SRMSE) between calculated and fitted data is low. Based on the original spreadsheets that fitted well with the model (n=87), we developed a simple prediction of the SRMSE and we used it as cutoff to check, correct (by removing enrichment data) and validate or remove the other spreadsheets. We found a cutoff dependent on the measured enrichment () that was. √∑(). And the mean SRMSE (90%CI) of the fitted sheets was 23.37 mg.kg-1 (22.01 mg.kg-1 , 24.73 mg.kg-1) with a maximum of 38.96 mg.kg-1. After correction we noticed that the number of enrichments removed per file varied from 1 to 4. We observed within the corrected spreadsheets a significant reduction (p≤0.0001, n=53) of the SRMSE (90%CI) from 49.78 mg.kg-1 (46.35 mg.kg-1 , 53.20mg.kg-1) before correction to 25.88 mg.kg-1 (24.13 mg.kg-1 , 27.64 mg.kg-1) after correction. We also observed that after correction, the mean difference (90%CI) of HM respectively non-HM that was 29.34 mg.kg-1 (21.71 mg.kg-1 , 36.97 mg.kg-1) respectively 24.13 mg.kg-1 (17.4 mg.kg-1 , 30.79 mg.kg-1) was strongly (p≤0.0001, n=53) different from zero. Therefore, the correction is very important to optimizing the results.

This lecture is part of the MA in International Higher Education Management at the University of Bath.  It covers TNE partnerships: scalability, profitability and sustainability:
1. What is TNE?
2. TNE in the landscape of internationalisation of higher education
3. Why the interest in TNE?
4. What are the main forms of TNE?
5. How important is TNE?
6. Characteristics of TNE partnerships
7. The scalability of TNE partnerships
8. How profitable is TNE?
9. Sustainability of TNE partnerships over time
10. Case studies of TNE partnerships

Doxofylline is a xanthine derivative and it has its application as a bronchodilator in different pulmonary conditions like asthma and COPD (chronic obstructive pulmonary disease). The research was conducted with the objective to develop and validate a simple, easy, rapid and cost-effective UV-Spectrophotometric method to estimate the amount of doxofylline in bulk and tablets. The validating parameters and methodology were selected and performed according to ICH and USP guidelines. In the accuracy study, the mean % recovery was within the limit (100.20%) with %RSD 0.77. The mean of % assay and %RSD of intra-assay precision study was found 99.81 and 0.79 respectively with only 0.57% variation between two analysts in intermediate precision study. The linearity study demonstrated the value of the correlation coefficient is 0.9999 whereas the robustness studies showed a slight but negligible variation of absorbance while changing different operating parameters. In system suitability study, the %RSD was found less than 2.00%. According to the specificity study, there were no placebo and diluent effect on the absorbance measurements.

Problematic gaming has become an emerging global health issue. Formal recognition of gaming disorder in the ICD-11 is a new opportunity for the discipline to conduct further investigation concerning the psychological consequences of problematic gaming. The present study investigated the psychometric properties and construct structure of the recently developed Gaming Disorder for Scale for Adolescents (GADIS-A) among Russian adolescent gamers, a multi-dimensional instrument that screens gaming disorder symptoms. The sample comprised 933 adolescent gamers (547 boys and 386 girls) recruited via a web-based platform, using a multistage sampling method. Analysis showed the GADIS-A had very good internal consistency (Cronbach's alpha coefficient= .891; Composite reliability= .89) and adequate testretest reliability after two weeks (intraclass coefficient, 68 with 95% CI [0.61, 0.77]. Exploratory structural equation modeling (ESEM) showed the data fitted well. Measurement invariance te...

This paper aims to establish a methodology for risk analysis of equipment and production systems, and identify those assets subject to the validation process. It's provides a set of instructions that describing in detail the steps to perform a validation schedule with bases residual risk. The study was conducted at the National Center for Scientific Research of Cuba, production department. The work is based on the implementation of the IEC 60812 standard, analysis of failure modes, effects and criticality (FMEA). In partnership with this standard it was used other documents necessary for application as the series of standards IEC 60300-3-1 and IEC 61025. Among the main results was obtained the risk map of the company and were implemented control actions once identified residual risk. These results allow to establish the minimum period necessary for validation of technological systems of the company.

Disulfide bonds are post-translational modifications that provide conformational stability to proteins relevant to perform their biological functions. In this study, the quantification of free thiols by using Ellman’s reagent was validated to presence of Valfor® zeolite NaA demonstrate, that the Filgrastim contained in the Filatil® exhibits the same amount of disulfide bonds than its reference product under both native and denaturing-reducing conditions. The validation exercise demonstrated to be suitable for its intended use. The comparability exercise for this attribute showed no significant differences (p=1.000; α, 0.05) in free
cysteines content among the two evaluated products. These results provide evidence of similitude for this attribute, which along with an extended comparability exercise for other physicochemical characteristics, contribute to the demonstration of similarity among the physicochemical and functional properties set as critical quality attributes for Filgrastim according to the regulatory guidelines.

Organizadoras: Ligia Gomes Elliot e Lúcia Regina Goulart Vilarinho.

Autores: Alexandre Ferreira de Oliveira, Ana Paula D’Oliveira dos Santos, Andreia Ferreira de Oliveira, Glauco da Silva Aguiar, Ligia Gomes Elliot, Lígia Silva Leite, Lúcia Regina Goulart Vilarinho, Luciane Pires da Silva, Margareth Braz Ramos e Renata Melo Nascimento.

Editora: Pimenta Cutural (2018)

ISBN: 
978-85-66832-97-6 (eBook)
978-85-66832-98-3 (brochura) 

DOI: 10.31560/pimentacultural/2018.983

OBJECTIVE: To develop and validate a Mandarin version of the Leeds Dyspepsia Questionnaire (M-LDQ) in Asian patients with dyspepsia. METHODS: The M-LDQ was developed according to standardized methods. The validity, internal consistency , test–retest reliability and responsiveness of the instrument were evaluated in both primary and secondary care patients. RESULTS: A total of 184 patients (mean age 54.0 ± 15.8 years, of whom 59% were women and 72.3% of whom had at least secondary level education) were recruited between August 2012 and March 2013, from both primary (n = 100) and secondary care clinics (n = 84). Both the internal consistency of all components of the M-LDQ (Cronbach's α 0.79) and test–retest reliability (Spearman's correlation coefficient 0.78) were good. The M-LDQ was valid in diagnosing dyspepsia in primary care (area under the receiver operating characteristics curve 0.84) and was able to discriminate between secondary and primary care patients (median cumulative LDQ score 13.0 vs 3.0, P < 0.0001). Among eight patients with organic dyspepsia, the median M-LDQ score reduced significantly from 21.0 (pretreatment) to 9.5 (4 weeks post-treatment) (P < 0.0001). CONCLUSION: The M-LDQ is a valid and responsive instrument for assessing ethnic Chinese adults with dyspepsia.

The digital marketing revolution and dynamic actions, organizations started focusing more on implementing strategies to find new prominent customer segments through digital marketing mediums [1]. Business analytics focuses on organizations to make fast, better and more intelligent decisions with the target to create business value [2]. Information Technology (IT)-driven big data analytics now has the potentiality to discover hidden facts in large amount of data to help in making business decisions which are customized to any organization needs. This paper is strive to create a machine learning model for sales customers data for campaign marketing straining lead data which will help in identifying interest and impressions on customer leads and important attributes influencing lead conversion to promote the digital media[3]. For the development of predictive data analytics model using CRISP methodology used and described each step in clearly.The Machine learning algorithm logistic Regression applied to find the approved conversions. Used Python for data Pre-processing, model development and validation. More clear about the predictive data analytics model & discussed the implementation steps involved in model development. To measure the quality of the model by using classification metrics which are confusion matrix and ROC curve and outcome of the metrics discussed [3]. The benefit of Machine learning model to get the approved conversion and the benefits of the model discussed.

Physicochemical and structural properties of proteins used as active pharmaceutical ingredients of bio-pharmaceuticals are determinant to carry out their biological activity. In this regard, the assays intended to evaluate functionality of biopharmaceuticals provide confirmatory evidence that they contain the appropriate physicochemical properties and structural conformation. The validation of the methodolo-gies used for the assessment of critical quality attributes of biopharmaceuticals is a key requirement for manufacturing under GMP environments. Herein we present the development and validation of a flow cytometry-based methodology for the evaluation of adalimumab's affinity towards membrane-bound TNF (mTNF) on recombinant CHO cells. This in vitro methodology measures the interaction between an in-solution antibody and its target molecule onto the cell surface through a fluorescent signal. The characteristics evaluated during the validation exercise showed that this methodology is suitable for its intended purpose. The assay demonstrated to be accurate (r 2 = 0.92, slope = 1.20), precise (%CV ≤ 18.31) and specific (curve fitting, r 2 = 0.986–0.997) to evaluate binding of adalimumab to mTNF. The results obtained here provide evidence that detection by flow cytometry is a viable alternative for bioassays used in the pharmaceutical industry. In addition, this methodology could be standardized for the evaluation of other biomolecules acting through the same mechanism of action.

The linguistic validation process of the Recovering Quality of Life (ReQoL) scale to the Indian language Tamil was undertaken by a team of mental health professionals at Schizophrenia Research Foundation, Chennai. The process involved the recommended forward and backward translation and review. A pilot testing was done involving Tamil speaking patients using the self-administered ReQoL. The translated Tamil version of ReQoL was considered acceptable. A detailed summary of the process is presented in the paper.

A simple, accurate, precise, sensitive and rapid high-performance thin-layer chromatographic (HPTLC) method of analysis for (ECO) Escitalopram oxalate and (CNM) Clonazepam in bulk drug and its formulations was developed and validated. The method employed TLC aluminum plates precoated with silica gel 60 F 254 as the stationary phase. The solvent system consisted of methanol: toluene: acetone (1: 3.5: 0.5 % v/v/v) as mobile phase. Densitometric analysis of escitalopram oxalate and clonazepam was carried out in the reflectance mode at 254 nm. Rf value was found to give compact spots for ECO and CNM was 0.24 ± 0.01 and 0.41± 0.02. The linear regression analysis data for the calibration plots showed good linear relationship in the concentration range 1000 – 5000 ng/band for Escitalopram oxalate and 100 – 500 ng/band for clonazepam. The mean value of correlation coefficient, slope and intercept were 0.9991, 1.5747 and 86.275 for Escitalopram oxalate, 0.9994, 20.1452 and 169.98 for clonazepam respectively. The limits of detection and quantitation were 26.112 and 79.1302 ng/band for ECO, 8.804 and 26.67 ng/band for CNM, respectively. The method was validated for precision, accuracy, specificity and robustness, stability as per International Conference on Harmonization guidelines for the routine analysis of Escitalopram oxalate and clonazepam in bulk and tablet dosage form in quality control laboratories.

The paper involves the development of a simple, precise and sensitive method for estimation of Apixaban in bulk drug and its
marketed formulation using the reverse-phase liquid chromatographic method. The separation was achieved on C18 INERTSIL
ODS-2 Column (250 mm×4.6 mm×5 um) using mobile phase (Buffer: ACN) in the ratio of 55:45(v/v) with a run time of 15
minutes and wavelength for estimation of Apixaban was taken as 280 nm. Literature survey reveals that there are very few
HPLC, UV methods were available Hence an attempt has been made to develop an RP-HPLC method for estimation of Apixaban.
The developed method was validated for Linearity, Accuracy (% Recovery), Precision, LOD, and LOQ etc. the linearity was
found to be in the range of 1-3 μg/ml with correlation coefficient found for linearity is 0.999. The developed and validated RPHPLC
method is applied for the identification of eluted.

Introduction: The Copenhagen Burnout Inventory (CBI) is a recent burnout measure with a focus on fatigue and exhaustion. It has three factors: personal burnout, workrelated burnout, and client-related burnout. This study aimed to translate the CBI into the Malay language and to validate the translated version among a group of medical students. Methods: The forwardebackward translation was performed as per standard guidelines. The Malay version of CBI (CBI-M) was distributed to 32 medical students to
assess face validity and later to 452 medical students to assess construct validity. The data analysis was performed by Microsoft Excel, SPSS and AMOS. Results: The face validity index of CBI-M was more than 0.8. The three factors of CBI-M achieved good levels of goodness-of-fit indices (Cmin/df ¼ 2.99, RMSEA ¼ 0.066, GFI ¼ 0.906, CFI ¼ 0.938, NFI ¼ 0.910, TLI ¼ 0.925). The composite reliability values of the three factors ranged from 0.84 to 0.87. The Cronbach’s alpha values of the three factors ranged from 0.83 to 0.87. Conclusions: This study supports the face and construct validity of the CBI-M with a high internal consistency. Keywords: Burnout; Copenhagen Burnout Inventory; Crosscultural issues; Scale development; Validation

The Business Process Model and Notation (BPMN) is the de-facto standard for representing in a very expressive graphical way the processes occurring in virtually every kind of organization one can think of, from cuisine recipes to the Nobel Prize assignment process, incident management, e-mail voting systems, travel booking procedures, to name a few. In this work, we give an overview of BPMN and we present what are the links with other well-known machineries such as BPEL and XPDL. We give an assessment of how the OMG's BPMN standard is perceived and used by practitioners in everyday business process modeling chores.

The article describes the process of translation and linguistic validation of Recovering Quality of Life (ReQoL) scale in Odia an eastern Indian language. While there are a few generic quality of life measures for use in health related subjects, there is none specific for mental health available in Odia. ReQoL is translated to Odia to bridge this gap. The translation and linguistic validation process was guided by the suggested methodology for translation of scales which involved forward and back-translation, pilot-testing involving patients, review and reconciliation steps. There were no major concerns in the translation process; the translated scale in Odia was observed to be easily comprehensible by the patients and useful in the clinical scenario.

The present paper on three related issues and their integration Product lifecycle management , Enterprise Planning resources and Manufacturing execution systems. Our work is how to integrate all these in a unified systems engineering framework. As most company about two third claim to have integrate ERP to PLM, ; we still observe some related problems as also mentioned by Aberdeen group. In actual global data sharing, we have some options to also integrate systems best practices towards such objective. Such critical study come with solution by reverse engineering, revisiting requirement engineering steps and propose a validation and verification for the success factors of such integration.

Seat is a sub system of automobile or vehicle. It is the main aggregate in a vehicle, which impacts the visibility, comfort, safety for the occupant. H-point plays vital role in seat system design & occupant safety. As a part of vehicle development, requirement raised is to have elevated H-point to have better visibility & control for occupant. Use of carryover seat with minimum part alterations is a challenge. After studying all relative factors, it has been decided to integrate carry over seat with BIW by addition of seat riser member. This paper speaks about design and development of seat riser member for automotive seat.

Purpose–The purpose of this paper is to introduce practitioners to the appropriate use of measures of unethical behaviour, evaluate the use of integrity-related assessments for use in personnel selection, and determine the validity of the moral competency index (MCI) instrument using standard validation procedures. Design/methodology/approach–Content, construct, convergent and discriminant approaches are applied to establish the relative validity of the assessment tool.

Purpose–The purpose of this paper is to introduce practitioners to the appropriate use of measures of unethical behaviour, evaluate the use of integrity-related assessments for use in personnel selection, and determine the validity of the moral competency index (MCI) instrument using standard validation procedures. Design/methodology/approach–Content, construct, convergent and discriminant approaches are applied to establish the relative validity of the assessment tool.

Background: To assess the psychometric properties, including internal consistency, construct validity, criterion validity, criterion-group validity, and responsiveness, the Reviewed McGill Quality of Life Questionnaire (MQOL-R), into Brazilian Portuguese-(BrP). Also, to analyze the relationship of the BrP-MQOL-R with the scores on the Karnofsky Performance Scale (KPS) and on the Numerical Pain Scale (NPS 0-10). Methods: The BrP-MQOL-R was administered to a sample of 146 adults (men = 78). A team of experts translated the MQOL-R according to international guidelines. Convergent validity and Confirmatory factor analysis (CFA) was performed. Results: The BrP-MQOL-R Cronbach's alpha was 0.85. CFA supported the original four-factor structure, with the following revised model fit-indices: PCLOSE = 0.131, Tucker-Lewis Index (TLI) rho 2 = 0.918, incremental fit index (IFI) delta 2 = 0.936. The convergence validity is supported by a significant correlation between BrP-MQOL-R total scores and their subscales with KPS and with the single item related to the quality of life. And by a converse correlation with the pain scores in the NPS (0-10). Receiver operator characteristics (ROC) analysis showed subjects with KPS equal to or lower than 30% could be discriminated from those with scores on KPS higher than 30% by an area under the curve (AUC) = 0.71, sensitivity = 97%, and specificity = 92%). Conclusion: The BrP-MQOL-R proves to be a reliable instrument for assessing the quality of life (QOL) in palliative care (PC), with primary evidence of validity. BrP-MQOL-R presented adequate discriminate properties to identify distinct conditions that impact the QOL in PC.