Near infrared (NIR)-spectroscopy and in-vitro dissolution absorption system 2 (IDAS2) can help detect changes in the quality of generic drugs.

While Health authorities in Panama strive to increase generic drug use to contain the rising costs of medicines, there is still hesitation to embrace generic drugs. Thus, regulators and drug companies need to ensure the quality, safety and efficacy of generic drugs. One prevailing concern is the absence of control over lot-to-lot changes, which may impact consistent therapeutic performance. The objective of this work was to determine whether near-infrared spectroscopy (NIR) could detect product changes. Calibration models were built using reference (standard) tablets of two products: Virax® (200 mg acyclovir) and Amlopin® (5 mg amlodipine). Then, to assess the sensitivity of NIR to product changes we compared reference versus deliberately-modified formulations of these products. Comparisons were made using principal component analysis (PCA) and partial least squares-discriminant analysis (PLS-DA) of NIR spectra. Several modified lots were different from reference lots, and 3D score plots showed greater discrimination by PLS-DA than PCA. The Kth nearest neighbor scores (KNN) of the modified batches were used to classify formulations as identical or not identical versus the reference. In addition, the differences detected by NIR were correlated with different in vitro dissolution and/or permeation in the in vitro dissolution absorption system 2 (IDAS2): NIR and IDAS2 yielded the same rank-order of difference for the modified lots tested. This study suggests that NIR and IDAS2 can help detect lots of generic drugs that differ from the reference lots. This strategy may help regulatory agencies in developing countries to safeguard patients against lot-to-lot changes in generic products.

Innovative in vitro methodologies for establishing therapeutic equivalence.

To improve the quality of pharmaceutical products in their markets, several Latin American countries have begun to require that new generic products demonstrate bioequivalence against innovator or reference products. However, given the number of products involved, it is not feasible to rely on clinical studies to comply with this requirement. Instead, it makes sense to adopt or develop strategies that are appropriate to the characteristics of the region. To streamline drug development and accelerate patients' access to quality drug products, 15 years ago the United States Food and Drug Administration (FDA) decided to grant exemptions from clinical bioequivalence studies (i.e., biowaivers) for certain types of drug products based on the Biopharmaceutics Classification System (BCS). Biowaivers can significantly reduce development time and cost and can also prevent unnecessary human exposure to potentially dangerous drugs while providing a robust, consistent standard for therapeutic equivalence of generic drug products. In addition, the limited success of translating in vitro dissolution data into in vivo performance can be enhanced using innovative tools such as the in vitro dissolution and absorption systems (IDAS). By integrating in vitro dissolution and permeability tests, these systems can provide useful insights for formulation development. A thorough assessment of the potential of in vitro techniques, along with formalization of their use through regulatory science initiatives when appropriate, may lead to cost-effective tools to help address some of the quality and regulatory challenges faced in the Latin American and Caribbean region.

Exploring the Effect of Halogenation in a Series of Potent and Selective A2B Adenosine Receptor Antagonists.

The modulation of the A2B adenosine receptor is a promising strategy in cancer (immuno) therapy, with A2BAR antagonists emerging as immune checkpoint inhibitors. Herein, we report a systematic assessment of the impact of (di- and mono-)halogenation at positions 7 and/or 8 on both A2BAR affinity and pharmacokinetic properties of a collection of A2BAR antagonists and its study with structure-based free energy perturbation simulations. Monohalogenation at position 8 produced potent A2BAR ligands irrespective of the nature of the halogen. In contrast, halogenation at position 7 and dihalogenation produced a halogen-size-dependent decay in affinity. Eight novel A2BAR ligands exhibited remarkable affinity (Ki < 10 nM), exquisite subtype selectivity, and enantioselective recognition, with some eutomers eliciting sub-nanomolar affinity. The pharmacokinetic profile of representative derivatives showed enhanced solubility and microsomal stability. Finally, two compounds showed the capacity of reversing the antiproliferative effect of adenosine in activated primary human peripheral blood mononuclear cells.

[Mantoux versus immunoferon-gamma test for diagnosis of latent tuberculosis infection in TB patient contacts]. / Mantoux frente a test de inmunoferón-γ para diagnóstico de infección tuberculosa latente en contactos con tuberculosis.

OBJECTIVE: To compare the sensitivity, specificity and efficiency between Mantoux and Interferon-gamma techniques, using secondary sources. DESIGN: Study of the published literature with a high evidence-based sources of scientific information. DATA SOURCES: A bibliographic search in the Cochrane database and Trip-database. STUDY SELECTION: We found three Clinical Practice Guidelines and nine articles, which included one Systematic Review, one Meta-analysis, one article on the sensitivity of the new techniques, three cost-efficiency studies, and three prospective studies on the role of interferon-gamma release in the diagnosis of TB. RESULTS: The new techniques have a higher specificity than Mantoux for the diagnosis of LTBI in contacts vaccinated in childhood with BCG. The most cost-effective diagnostic strategy for LTBI was Mantoux screening and confirmation with QFT-G. CONCLUSION: Resources should be coordinated, limiting its use in studies of contacts in immunocompetent adults vaccinated with BCG, with Mantoux>5mm or Tuberculin doubtful cases.

Computerization of a preanesthetic evaluation and user satisfaction evaluation.

Preanesthetic evaluation purpose is to reduce morbidity and mortality through the review of the patient's medical history, clinical examination, and targeted clinical studies, providing referrals for medical consultations when appropriated. Changes in patient care, standards of health information management and patterns of perioperative care, have resulted in a re-conceptualization of this process where the documentation of patient medical information, the efforts in training and maintaining the integrity of the medical-legal evaluation are areas of concern. The aim of this paper is to describe the design, development, training, and implementation of a computerized preanesthetic evaluation form associated to the evaluation of the user satisfaction with the system. Since the system went live in September 2008 there were 15121 closed structured forms, 60% for ambulatory procedures and 40 % for procedures that required hospital admission. 82% of total closed structured forms had recorded a risk of the procedures of 1-2, according to the American Society of Anesthesiologists classification. The survey indicates a positive general satisfaction of the users with the system.

Development and implementation of an integrated EHR for Homecare Service: a South American experience.

This paper describes the development and implementation of a web based electronic health record for the Homecare Service program in the Hospital Italiano de Buenos Aires. It reviews the process of the integration of the new electronic health record to the hospital information system, allowing physicians to access the clinical data repository from their Pc's at home and with the capability of consulting past and present history of the patient health care, order, tests, and referrals with others professionals trough the new Electronic Health Record. We also discuss how workflow processes were changed and improved for the physicians, nurses, and administrative personnel of the Homecare Services and the educational methods used to improve acceptance and adoption of these new technologies. We also briefly describe the validation of physicians and their field work with electronic signatures.

Defensive pessimism, self-esteem and achievement goals: A person-centered approach.

BACKGROUND: The relationship between defensive pessimism, self-esteem, and achievement goals is a controversial issue. The main contribution of this research is the adoption of a person-centered approach to explore the existence of differentiated profiles of university students, which combine self-esteem and defensive pessimism. In addition, we analyze whether these profiles differ in their achievement goals (learning, performance-approach, performance-avoidance, and work-avoidance). METHOD: 1,028 university students took part in the study. RESULTS: Four student profiles were identified: (a) HSE/MDP (high self-esteem and moderate defensive pessimism); (b) LSE/LDP (low self-esteem and low defensive pessimism); (c) HSE/LDP (high self-esteem and low defensive pessimism); and (d) LSE/HDP (low self-esteem and high defensive pessimism). These four profiles differ significantly in their achievement goals. CONCLUSIONS: The use of defensive pessimism may involve students with either low or high self-esteem, although the two profiles follow differentiated motivational achievement trajectories.

[Occupational Exposure to Psychosocial Factors and Presence of Musculoskeletal disorders in Nursing Staff: A review of Studies and Meta-Analysis]. / Asociación entre la exposición laboral a factores psicosociales y la existencia de trastornos musculoesqueléticos en personal de enfermería: revisión sistemática y meta-análisis.

BACKGROUND: There is scientific evidence that psychosocial factors are significantly associated with discomfort and / or pain musculoskeletal complaints in nursing staff. The objective of the research was to analyze the association between occupational exposure to psychosocial factors at work and musculoskeletal damage in nursing staff. METHODS: Systematic review and meta-analysis of studies published up to 2015 in English, French, Italian, Portuguese or Spanish evaluating the association between musculoskeletal disorders and psychosocial factors in the work of nursing staff. A search was made using the same strategies in the bibliographic databases Web of Science, MEDLINE (Pubmed), NIOSHIC and CINAHL. We assessed the quality of eligible studies, heterogeneity, and sensitivity analyzes. RESULTS: 64 studies were reviewed and quality criteria were accepted, accepting those of medium and high quality (n = 47). In a second screening, those that did not meet inclusion criteria were eliminated, with 36 studies being included in the meta-analysis. Statistically significant associations were found between high demands with discomfort and / or pain neck (OR 1.55, IC95%: 1.39-1.72). And between the effort-reward imbalance with discomfort and / or pain in any body region (OR 2.56, IC95%: 1.59-4.11). Heterogeneity was generally average and low for most subsets of the meta-analysis. CONCLUSIONS: Occupational exposure to psychosocial factors is associated with discomfort and / or pain in different body areas. Therefore, the improvement of the psychosocial environment has an impact on the reduction and prevention of musculoskeletal disorders.

OBJETIVO: Hay evidencias científicas de que los factores psicosociales están significativamente asociados con molestias y/o dolencias musculoesqueléticas en personal de enfermería. El objetivo de la investigación fue analizar la asociación entre la exposición laboral a factores psicosociales en el trabajo y la existencia de daño musculoesquelético en personal de enfermería. METODOS: Revisión sistemática y metaanálisis de estudios publicados hasta 2015 en inglés, francés, italiano, portugués o español que evaluaron la asociación entre daño musculoesquelético y factores psicosociales en el trabajo del personal de enfermería. Se realizó una búsqueda utilizando las mismas estrategias en las bases bibliográficas Web of Science, MEDLINE (Pubmed), NIOSTHIC y CINAHL. Se evaluó la calidad de los estudios elegibles, su heterogeneidad y se realizaron análisis de sensibilidad. RESULTADOS: Se revisaron 64 estudios a los que se les aplicó criterios de calidad, aceptando los que tenían calidad media y alta (n=47). En una segunda criba se eliminaron los que no cumplían los criterios de inclusión, siendo 36 los estudios que fueron incluidos en el metaanalisis. Se encontraron asociaciones estadísticamente significativas entre altas demandas con molestia y/o dolor en cuello (OR 1,55; IC95% 1,39-1,72) y entre el desequilibrio esfuerzo-recompensa con molestia y/o dolor en cualquier región corporal (OR 2,56; IC95% 1,59-4,11). CONCLUSIONES: La exposición laboral a factores psicosociales se asocia con molestia y/o dolor en diferentes zonas corporales. Por tanto, la mejora del ambiente psicosocial tiene un impacto en la reducción y prevención de los trastornos musculoesqueléticos.

Conducta prosocial y motivación académica en estudiantes españoles de Educación Secundaria Obligatoria / Prosocial behavior and academic motivation in Spanish High School Students

Este estudio analizó la relación entre conducta prosocial y metas académicas en una muestra de 2.022 estudiantes españoles. La conducta prosocial fue medida con la escala de Conducta Prosocial del Teenage Inventory of Social Skills (TISS) y las metas académicas mediante el Achievement Goal Tendencies Questionnaire (AGTQ). Los resultados revelaron que los estudiantes con alta conducta prosocial presentaron puntuaciones significativamente más altas en metas de aprendizaje y logro. La conducta prosocial fue un predictor positivo y estadísticamente significativo de metas de aprendizaje y logro. Además, las metas de aprendizaje y logro fueron predictores positivos y estadísticamente significativos de la conducta prosocial, mientas que las metas de refuerzo social fueron un predictor negativo y estadísticamente significativo de la conducta prosocial.

his study analyzed the relationship between prosocial behaviour and academic goals in a sample of 2,022 Spanish compulsory secondary education students. The prosocial behaviour was measured with the Prosocial Behaviour scale of the Teenage Inventory of Social Skills (TISS) and academic goals were measured with the Achievement Goal Tendencies Questionnaire (AGTQ). The results revealed that students with high prosocial behaviour presented higher significantly scores in learning and performance goals. Theprosocial behaviour was a positive and statistically significant predictor of learning and performance goals. Furthermore, learning and performance goals were positive and statistically significant predictors of the prosocial behaviour, whereas social reinforcement goals were a negative and statistically significant predictor of prosocial behaviour.

Perfiles motivacionales y diferencias en variables afectivas, motivacionales y de logro / Motivational profiles and differences in affective, motivational and achievement variables

En este trabajo se pretende identificar si existen combinaciones de múltiples metas que dan lugar a diferentes perfiles motivacionales. La muestra está integrada por 1924 estudiantes universitarios. A través del análisis de conglomerados se han identificado seis perfiles motivacionales. Los resultados indican que el perfil motivacional que engloba a los estudiantes que están motivados para aprender, pero también para conseguir mejores resultados que los demás y para evitar dar una mala imagen ante ellos, son los que informan de un mejor rendimiento académico y los que creen también tener un nivel más alto de conocimientos en las materias académicas que están cursando. Por otro lado, los estudiantes con un perfil motivacional orientado al aprendizaje son los que hacen una valoración más alta de las tareas, los que tienen un mayor grado de control sobre su proceso de aprendizaje, y los que tienen unos niveles más bajos de ansiedad.

The purpose of this work is to identify whether there are combinations of multiple goals that lead to different motivational profiles. The sample is made up of 1924 university students. By means of cluster analysis, six motivational profiles were identified. The results indicate that the motivational profile that comprises students who are motivated to learn, but also to achieve better results that the rest and to avoid making a bad impression on them are the students who report better academic achievement and also the students who believe they have a higher level of knowledge in the academic subjects they are studying. However, students with a learning oriented motivational profile value the tasks more, have more control over their learning process, and have lower levels of anxiety.

Aceite ozonizado: alternativa efectiva para las úlceras varicosas de miembros inferiores en Atención Primaria / Ozonized oil: an effective alternative treatment for lower limb varicous ulcers at Primary Health Care System

La úlcera varicosa es una complicación frecuente en la insuficiencia venosa de los miembros inferiores que condiciona múltiples trastornos locales y sistémicos, con una mala calidad de vida del paciente. El objetivo del presente trabajo fue evaluar el efecto cicatrizante del oleozón en ulceras varicosas de los miembros inferiores en la atención primaria. Se tomó una muestra de 60 pacientes con úlceras varicosas en miembros inferiores que fueron divididos en dos grupos: A) 30 tratados con oleozón®, B) 30 tratados convencionalmente, de forma ambulatoria desde enero de 2007 hasta mayo de 2008. Se consideró como buen resultado cuando a los 45 días de tratamiento o antes, el paciente presentó una remisión parcial o total y se consideró fracasado cuando no hubo remisión. Se utilizó la prueba de comparación de frecuencias de X² al 95 % de confianza y obtuvo un incremento significativo del doble de casos con remisión total bajo tratamiento con oleozón®, de manera que la eficacia quedó comprobada para el tratamiento ambulatorio en la Atención Primaria de Salud, de las úlceras varicosas de miembros inferiores, rebeldes a tratamiento convencional.

Varicous ulcers are frequent complications of the venous insufficiency of the lower limbs, leading to multiple local and systemic impairments, producing patients having bad quality of life. The aim of the present paper was to evaluate the scarring effect of oleozón®, on various ulcers of the lower limbs at the Primary Health Care level. A sample of60 patients were divided into two groups: A) 30 patients, receiving ozonized oil (oleozón®), B) 30 patients conventionally treated, in ambulatory way since January 2007 to May 2008. A good result was considered when after 45 days of treatment or before that time a partial or total remission was obtained, and failure when no remission was observed. X2 test was used to compare frequencies at 95 % of certainty. There was two fold number of cases under on remission in group A, showing the efficacy of the treatment, otherwise rebels to the conventional treatment.

Evaluación de la calidad del registro de cáncer: provincia Pinar del Río, año 2005 / Assessment of the quality of the record of cancer: Pinar del Rio Year 2005

La calidad del Registro de Cáncer depende mucho de la información que se maneja, y ésta a su vez, depende de la veracidad del diagnóstico de cáncer que se obtiene a partir de la confirmación histológica. El objetivo de esta investigación consiste en evaluar la calidad del Registro Provincial de Cáncer en Pinar del Río durante el año 2005, detectar sus logros y deficiencias. Se realizó un estudio descriptivo y transversal de la morbilidad por cáncer al 100 % de los casos reportados, así como los reportados sólo por certificados de defunción, para calcular tasa de incidencia, mortalidad bruta y específica por grupos de edades y sexos, y evaluación de los indicadores estandarizados por el registro nacional. En los resultados se detectaron que 571 pacientes fueron reportados sólo por certificados de defunción, modificando las tasas de incidencia en el sexo femenino de 18,5 a 24-7 y en el masculino de 10,9 a 20,3, provincialmente se incrementa en 7,8 por 10000 habitantes. Se detectó mayor subregistro en el sexo masculino y en el grupo de 70-79 años. Provincialmente sólo se reportó el 56,2% de las biopsias positivas. La calificación según indicadores nacionales solamente llegó a 55 puntos, demostrándose que la calidad del registro fue baja.

The quality of the record of cancer depends to a large extent of the information available and it at turn depends of the truthfulness of the cancer diagnosis which is obtained from the histological confirmation. In order to evaluate the quality of the provincial record in Pinar del Rio during year 2005, a descriptive and cross sectional study on the morbidity due to cancer was performed in all cases reported in order to study how it influences unfavourably on the information only by means of the death records from patients who died with this disease , and also it allows us to estimate the rate of incidence, the specific mortality rate in groups according to age and sex , which influence on the evaluation of the quality of the record and the different standard indicators of the national record. 571 patients were only reported by death record modifying the incidence rates in female (from 18, 5 to 24, 7) and (from 10, 9 to 20, 3) in males. It was observed an increase of 7, 8 by 10000 habitants. The percentual distribution showed a higher sub record in males and in the group from 70-79. It was only reported 56, 2% of positive biopsies. The evaluation of the indicators showed that the quality of the record was low and the score achieved a bad qualification (55 marks).

Las estrategias de aprendizaje: revision teorica y conceptual / Learning strategies: theoretical and conceptual analysis

Se presenta un análisis teórico y conceptual de las estrategias de aprendizaje, uno de los temas mas importantes en los últimos años dentro de la Psicología la Educación. Las cuestiones esenciales que se abordan son las siguientes: el concepto de estrategia, los procesos y etapas implicados, los diferentes sistemas de clasificación, y la enseñanza de estrategias de aprendizaje.