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Similar biotherapeutic products in Latin America. Regulation and opportunities for patients with autoimmune diseases
Desanvicente-Celis Z, Caro-Moreno J, Enciso-Zuluaga M, Anaya JM
Biosimilars , 2013, DOI: http://dx.doi.org/10.2147/BS.S38572
Abstract: r biotherapeutic products in Latin America. Regulation and opportunities for patients with autoimmune diseases Review (2281) Total Article Views Authors: Desanvicente-Celis Z, Caro-Moreno J, Enciso-Zuluaga M, Anaya JM Published Date January 2013 Volume 2013:3 Pages 1 - 17 DOI: http://dx.doi.org/10.2147/BS.S38572 Received: 27 September 2012 Accepted: 03 November 2012 Published: 04 January 2013 Zayrho Desanvicente-Celis, Julian Caro-Moreno, Mateo Enciso-Zuluaga, Juan-Manuel Anaya Center for Autoimmune Diseases Research (CREA), Universidad del Rosario, Bogotá, Colombia Abstract: Biotherapeutic products have revolutionized medicine, changing the way we can treat some chronic diseases, such as autoimmune diseases. The patent expiry and the high costs of reference biotherapeutic products, among other factors, have promoted interest in similar biotherapeutic products (SBPs), also known as biosimilars. The objective of developing an SBP is to manufacture a “highly similar” molecule to a reference biotherapeutic product, by conducting a comparability exercise that can demonstrate similar quality, safety, and efficacy. Regulations like those of the World Health Organization, the European Medicines Agency, and the Food and Drug Administration are international reference standards. Herein, we aim to point out the current status in Latin America on SBPs, focusing on regulatory issues within the context of autoimmune diseases. The regulations of Argentina, Peru, Chile, Guatemala, Panama and Costa Rica follow the World Health Organization guidelines. Other countries, such as Cuba, Mexico, Venezuela, and Brazil have regulations that take into account international standards combined with local features. In Colombia, a draft decree is under revision and the debate is ongoing. Some countries have already approved SBPs. Mexico, Chile, Ecuador, Bolivia, and Peru market SBPs of rituximab, and Colombia markets an SBP of etanercept. The advent of SBPs is definitely beneficial. Safety and efficacy must be ensured following clear and comprehensive regulations.
Inter-Industry Productivity Spillovers from Japanese and US FDI in Mexico’s Manufacturing Sector  [PDF]
Leo Guzmán Anaya
Technology and Investment (TI) , 2013, DOI: 10.4236/ti.2013.44028
Abstract:

Foreign Direct Investment can have positive effects on host countries by generating spillovers to domestic firms and contributing to increases in their productivity. These productivity spillovers1 can take place within an industry (intraindustry spillovers) and across industries (inter-industry spillovers) as in the case of technology or knowledge transfer to domestic suppliers (backward productivity spillovers) or customers (forward productivity spillovers). Using unpublished economic census data from Mexico’s manufacturing sector this study differs from others by comparing interindustry productivity spillovers from Japanese and US FDI. Results show that Japanese FDI increases the productivity of upstream sectors; however these gains seem to be shared only among foreign suppliers, while US FDI does not seem to generate backward productivity spillovers. Results show no presence of forward productivity spillovers.

The autoimmune tautology
Juan-Manuel Anaya
Arthritis Research & Therapy , 2010, DOI: 10.1186/ar3175
Abstract: Autoimmune diseases are chronic conditions initiated by the loss of immunological tolerance to self-antigens and represent a heterogeneous group of disorders that afflict specific target organs or multiple organ systems. The chronic nature of these diseases places a significant burden on the utilization of medical care, direct and indirect economic costs, and quality of life. Almost all autoimmune diseases disproportionately affect middle-aged women and are among the leading causes of death for this group of patients. With increasing age of patients, the female-to-male ratio for autoimmune diseases becomes more prominent.The autoimmune tautology refers to the fact that autoimmune diseases share several clinical signs and symptoms, physiopathologic mechanisms, and genetic factors and this fact indicates that they have a common origin (Table 1). In the previous issue of Arthritis Research & Therapy, Eyre and colleagues [1] report that variation within the TAGAP gene, at 6q25.3, is associated with three autoimmune diseases, namely rheumatoid arthritis, type 1 diabetes, and coeliac disease, in Caucasians. In addition, the authors confirmed other loci associated with these diseases in their population: CTLA-4, the IL2-21 region, 6q23 (TNFAIP3), SH2B3, PRKCQ, and MMEL1 [1].The impact of genetic predisposition on susceptibility to autoimmune diseases was first identified by the analysis of disease concordance rates in monozygotic twins (concordance rates ranged from about 15% to 57%) [2]. The decrease in the concordance rates of siblings compared with the rate among monozygotic twins supports the presence of multiple genes contributing to the autoimmune phenotype onset.A primary characteristic of complex diseases is that affected individuals tend to cluster in families (that is, familial aggregation, also referred to as recurrence risk). Recurrent associations of autoimmune diseases in family members of patients have been reported. Although non-genetic factors may have an
ámbito de aplicación en el tiempo de la Legislación Laboral Venezolana
Madriz Anaya,Raiza Mercedes;
Gaceta Laboral , 2005,
Abstract: laws enter into force on a determined date and disappear on another certain date, and situations can occur in which the effects they produce are prolonged over time. this problem is called ？retroactivity of laws？. the dynamic nature of labor law, reflected in the continual modifition of the rules applied to every work relationship, the interpretation concerning the determination of the temporary effectiveness of the rules. this is considered the most difficult aspect of the general theory of the temporary legal effect of the law. the principle of non-retroactivity of the laws is established in article 24 of the national constitution of venezuela, which predicates the non-applicability of laws retroactively, save the exceptions established in criminal matters. because they are of interest to public order, labor rules are immediately applicable, and they are in force both for work relationship that are establish after they take legal effect, as well as for the legal consequences originated afterwards. in collective or individual labor contracts, the retroactivity of certain clauses prior to a new labor provided they are more favorable to the workers and based on constitutional and labor principles.
DVD Review: September 11: 11 Directors, 11 Stories, 1 Film
Ella Ruth Anaya
Global Media Journal : Canadian Edition , 2011,
Abstract:
El videoclip como eje central de la actividad en el aula: Tanto la quería, de Andy y Lucas
Vanessa Anaya Moix
Foro de Profesores de E/LE , 2008,
Abstract: La propuesta que quiero presentaros se basa en la utilización del videoclip (en este caso, Tanto la quería, de Andy y Lucas) como eje central de la actividad en el aula.Se trata de una propuesta que realicé con alumnos de nivel A2 y que me funcionó muy bien. Os aconsejo que realicéis esta actividad una vez que los alumnos conozcan los distintos pasados.
ámbito de aplicación en el tiempo de la Legislación Laboral Venezolana
Raiza Mercedes Madriz Anaya
Gaceta Laboral , 2005,
Abstract: Las Leyes entran en vigor en una fecha determinada y desaparecen en otra fecha cierta, pudiéndose dar el caso que los efectos que producen se retrotraen en el tiempo. Este problema es conocido con el nombre de “Retroactividad de las Leyes”, cuyo principio fundamental es la “Irretroactividad de las Leyes”. La naturaleza dinámica del Derecho del Trabajo, reflejada en la modificación continua de la normativa aplicada a toda relación laboral y cuyo cumplimiento se proyecta regresivamente en el tiempo, ha dado nacimiento a problemas de interpretación relativos a la determinación de la eficacia temporal de sus normas, siendo considerado esto, como lo más difícil de la Teoría General del Derecho, específicamente de la Teoría General de la Vigencia Temporal de la Ley. El principio de Irretroactividad de las Leyes se encuentra establecido en el artículo 24 de la Constitución Nacional Venezolana, el cual predica la ausencia de aplicabilidad de las leyes retroactivamente, salvo las excepciones establecidas en materia penal. Por interesar al orden público, las normas laborales tienen aplicación inmediata, y rigen tanto para las relaciones laborales que se establezcan después de su vigencia, como para las consecuencias jurídicas originadas con posterioridad a la misma, y en los contratos colectivos o individuales de trabajo se debe respetar la retroactividad de algunas cláusulas anteriores a la vigencia de una nueva ley laboral y/o celebración de un nuevo contrato, siempre que favorezcan más a los trabajadores y se encuentren fundamentadas por principios constitucionales y laborales. Laws enter into force on a determined date and disappear on another certain date, and situations can occur in which the effects they produce are prolonged over time. This problem is called “Retroactivity of Laws”. The dynamic nature of labor law, reflected in the continual modifition of the rules applied to every work relationship, the interpretation concerning the determination of the temporary effectiveness of the rules. This is considered the most difficult aspect of the General Theory of the temporary Legal Effect of the Law. The principle of non-retroactivity of the laws is established in Article 24 of the National Constitution of Venezuela, which predicates the non-applicability of laws retroactively, save the exceptions established in criminal matters. Because they are of interest to public order, labor rules are immediately applicable, and they are in force both for work relationship that are establish after they take legal effect, as well as for the legal consequences originate
Rese a de "La utopía del regreso. La cultura del nacionalismo hispanista en América Latina" de Carlos M. Tur Donatti
MARIO MAGALLóN ANAYA
Latinoamérica. Revista de estudios Latinoamericanos , 2008,
Abstract:
Filosofía de la educación para la liberación en la América latina del siglo XXl: entender la realidad del siglo XX y su proyección hacia el siglo XXl a través del lenguaje
Mario Magallón Anaya
Latinoamérica. Revista de estudios Latinoamericanos , 2005,
Abstract: La cultura debe ser concebida como un elemento esencial para la educación, la formación, el mejoramiento y la perfección de los seres humanos. La cultura tiene que ser entendida como el conjunto de los modos de vivir y pensar en el tiempo y en un espacio histórico-social. Es allí donde la educación ha desempe ado un papel central para entendernos, hacernos comprender y comunicarnos a través de las diversas formas expresivas humanas. Destaca de manera especial el lenguaje, en sus diversas formas, porque es por éste, que el espíritu humano razona y comprende.
Rese a de "Francisco de Vitoria. Espa a y América. El poder y el hombre" de María del Carmen Rovira Gaspar
Mario Magallón Anaya
Latinoamérica. Revista de estudios Latinoamericanos , 2006,
Abstract:
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