Development and Preliminary Validation of a Scale to Measure Perceived Therapist's Knowledge about Gender Identity Diversity among Trans and Non-Binary Individuals in Puerto Rico.

This study aimed to describe the development of the Perceived Therapist's Knowledge about Gender Identity Diversity Scale and to preliminarily validate this scale by describing its psychometric properties. This research instrument was constructed based on the existing literature and recommendations for instrument development. Initially, a 36-item scale was devised to assess perceived openness and knowledge about gender identity diversity in therapy. The content validation process involved 12 expert judges, leading to a refined 25-item scale. Participants consisting of 57 trans and non-binary Puerto Rican individuals completed the scale. Exploratory factor analysis revealed a unidimensional structure, supporting a single factor named "perceived knowledge about gender identity diversity in therapy." The final scale demonstrated excellent reliability (α = 0.978; Sα = 0.980; ω = 0.979), indicating strong internal consistency. This validated scale contributes to assessing primarily Hispanic trans and non-binary individuals' perceptions of their therapists' knowledge about gender identity diversity.

Development and validation of a stability indicating high performance liquid chromatography method for trimethobenzamide

A simple, accurate, precise and robust stability indicating RP-HPLC assay method has been developed for the estimation of trimethobenzamide in stress sample. An isocratic separation of trimethobenzamide was achieved on Kromasil 100 C-18 column (250 X 4.6mm, 5µ) with a flow rate of 1.0 ml/min and by using a photodiode array detector to detect the analyte at 213nm. The optimized mobile phase consisted of methanol: ammonium formate (44:56, v/v). The drug was subjected to different forced degradation conditions according to ICH guidelines including acid, base, neutral hydrolysis, oxidation, photolysis and thermal degradation. Degradation products were found only in basic and oxidative degradation conditions. All the degradation products got eluted in an overall analytical run time of 12min. The developed analytical method has been validated according to the ICH guidelines. Response of trimethobenzamide was linear over the concentration range of 0.5-50µg/mL (r2 = 0.999). Accuracy was found to be in between 94.03% to 100.39%. Degradation products resulting from the stress studies did not interfere with the detection of the analyte.

Validation of a Cell Proliferation Assay to Assess the Potency of a Dialyzable Leukocyte Extract Intended for Batch Release.

Transferon® is a blood product with immunomodulatory properties constituted by a complex mixture of peptides obtained from a human dialyzable leukocyte extract (DLE). Due to its complex nature, it is necessary to demonstrate batch consistency in its biological activity. Potency is the quantitative measure of biological activity and is also a quality attribute of drugs. Here we developed and validated a proliferation assay using Jurkat cells exposed to azathioprine, which is intended to determine the potency of Transferon® according to international guidelines for pharmaceuticals. The assay showed a linear response (2.5 to 40 µg/mL), coefficients of variation from 0.7 to 13.6% demonstrated that the method is precise, while r2 = 0.97 between the nominal and measured values obtained from dilutional linearity showed that the method is accurate. We also demonstrated that the cell proliferation response was specific for Transferon® and was not induced by its vehicle nor by other peptide complex mixtures (glatiramer acetate or hydrolyzed collagen). The bioassay validated here was used to assess the relative potency of eight released batches of Transferon® with respect to a reference standard, showing consistent results. The collective information from the validation and the assessment of several batches indicate that the bioassay is suitable for the release of Transferon®.

Desarrollo y validación de una escala para medir satisfacción con los recursos laborales / Development and validation of a measure of satisfaction with job resources

Resumen En los últimos 30 años la investigación empírica ha mostrado consistentemente la influencia positiva de los recursos laborales en el bienestar y desempeño de los trabajadores. Sin embargo, se ha señalado que estos resultados positivos se asocian más con la satisfacción percibida que con los recursos provistos por la organización. En esta línea y tomando como referencia el modelo HERO se diseñó un instrumento para medir la satisfacción con los recursos laborales. Los análisis factoriales exploratorio y confirmatorio utilizando muestras de 492 y 508 trabajadores, respectivamente, respaldaron las cuatro dimensiones teóricas propuestas: satisfacción con los recursos de tarea, satisfacción con los recursos de equipo, satisfacción con los recursos de líder y satisfacción con los recursos de la organización. Se obtuvieron índices satisfactorios de consistencia interna y de fiabilidad del constructo, y evidencias de validez test-criterio con medidas de engagement y burnout. Se discute el valor práctico del nuevo instrumento y algunas sugerencias tendientes a examinar en mayor profundidad sus propiedades psicométricas.

Abstract Over the past three decades research on job resources has consistently shown their influence on employees' well-being and performance. However, recent studies indicate that such outcomes are more strongly related to satisfaction with job resources than to perceived job resources. Accordingly, and based on HERO model, we developed a new measure to assess satisfaction with job resources. Exploratory and confirmatory factor analytic-results based on two independent samples consisting of 492 and 508 employees supported the four proposed dimensions: satisfaction with task resources, satisfaction with team resources, satisfaction with leader/supervisor resources, and satisfaction with organizational resources. Reliability analyses showed good internal consistency and construct reliability for the dimensions, and relations with burnout and work engagement scales supported for criterion validity. Practical implications of the new measure are discussed, and we also made some suggestions to examine the psychometric properties of the scale in a more substantial degree.

Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms

A simple, accurate, isocratic stability indicating RP-HPLC method was developed for the determination of cefepime and amikacin in Pure and its pharmaceutical formulations. The method consists of methanol: acetonitrile:acetate buffer 75:20:05 (v/v) mobile phase at pH 5.1 with C18 column as stationary phase. The flow rate and detection wave length were 1.0 mL/min and 212 nm respectively. The linearity range for the method was found to be 2.5-25 µg/mL for amikacin and 10-100 µg/mL cefepime respectively. The developed method was validated as per ICH guidelines and the results of all the validation parameters were well within their acceptance values. Also the forced degradation studies were conducted with standard drugs. Degradation products formed during the different stress conditions were separated from both drugs. This validated method was applied for the simultaneous estimation of cefepime and amikacin in commercially available formulation sample.

Design and validation of LupusCol, an instrument for the evaluation of health-related quality of life in Colombian adult patients with systemic lupus erythematosus.

OBJECTIVE: The aim of this study was to design and validate LupusCol, an instrument for the evaluation of health-related quality of life (HRQoL) in Colombian adult patients with SLE. METHODS: Items and domains of the initial instrument were defined. Preliminary tests were made with the participation of patients. Validity and reliability tests of the administration method were conducted. Usability tests were applied to the version obtained in the previous phases to complete the validation process. RESULTS: Following preliminary tests, six items and one domain were excluded and two new items were added to the instrument, producing a form with 44 questions and 7 domains, which was submitted for validity and reliability tests. Factor analysis excluded three items, obtaining a Pearson's correlation (PC) for the criteria validity of -0, 48; a Cronbach's α coefficient for internal consistency of 0, 96; an intraclass correlation coefficient (ICC) for personal test-retest-telephone of 0.96 and an ICC personal test-retest-personal of 0.96. For interrater concordance a PC of 0.8, an ICC of 0.77 and a Lin's coefficient of 0.86 were found. Sensitivity to change was demonstrated through analysis of variance, obtaining significant indicators about the scale, demonstrating the instrument's ability to detect changes in HRQoL. CONCLUSION: The design and validation process was completed successfully. The scale has significant values for validity, reliability and sensitivity to change in the studied population.