RESUMO
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.
Assuntos
Medicamentos Genéricos , Espectroscopia de Luz Próxima ao Infravermelho/métodos , Química Farmacêutica/métodos , Análise de Componente PrincipalAssuntos
Hipertensão Pulmonar/etiologia , Embolia Pulmonar/fisiopatologia , Embolia Pulmonar/cirurgia , Trombectomia/efeitos adversos , Função Ventricular Direita , Doença Aguda , Adulto , Idoso , Ecocardiografia , Hemorragia , Humanos , Hipertensão Pulmonar/complicações , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Embolia Pulmonar/complicações , Terapia Trombolítica , Disfunção Ventricular DireitaRESUMO
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.
Para mejorar la calidad de los productos farmacéuticos comercializados en su mercado, varios países latinoamericanos han empezado a exigir que se demuestre la bioequivalencia de los nuevos medicamentos genéricos frente a los medicamentos innovadores o de referencia. Sin embargo, dado el gran número de medicamentos, resulta, poco factible realizar estudios clínicos para cumplir con este requisito pero tiene sentido incorporar o elaborar estrategias que sean acordes a las características de la región. Para simplificar el desarrollo de fármacos y optimizar el acceso de los pacientes a medicamentos de buena calidad, hace 15 años la Administración de Alimentos y Medicamentos de los Estados Unidos de América (FDA) decidió conceder exenciones a la realización de estudios clínicos de bioequivalencia (es decir, bioexenciones) a algunos tipos de medicamentos conforme al Sistema de Clasificación Biofarmacéutica. Las bioexenciones reducen significativamente el tiempo y el costo de desarrollo, y también evitan la exposición innecesaria de seres humanos a medicamentos que podrían ser nocivos, a la vez que constituyen una norma robusta y uniforme que garantiza la equivalencia terapéutica de los medicamentos genéricos. Por otra parte, los métodos innovadores, como los sistemas de disolución y absorción in vitro, permiten ampliar los resultados limitados obtenidos al aplicar los datos de disolución in vitro para simular los efectos in vivo. Dado que combinan las pruebas de disolución in vitro con las de permeabilidad, estos sistemas brindan conocimientos útiles para el desarrollo galénico. Es probable que la evaluación meticulosa del potencial de las técnicas in vitro, junto con su formalización mediante iniciativas de normalización científica cuando corresponda, permita concebir métodos eficaces en función de los costos que ayuden a encarar algunos de los retos relativos a la calidad y la regulación de los medicamentos que enfrentan América Latina y el Caribe.
Assuntos
Biofarmácia , Dissolução , Permeabilidade , Absorção , Equivalência Terapêutica , Controle de Qualidade , Biofarmácia , Dissolução , Permeabilidade , Absorção , Equivalência Terapêutica , Controle de QualidadeRESUMO
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.
Assuntos
Comportamento do Adolescente , EnsinoRESUMO
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.
Assuntos
Anestesia/normas , Registros Eletrônicos de Saúde , Informática Médica/métodos , Cuidados Pré-Operatórios , Computadores/estatística & dados numéricos , Documentação , Humanos , Satisfação PessoalRESUMO
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.