Abstract The COVID-19 pandemic has shed light on the negative impact of intellectual property on health and has given new relevance to the Direct Action of Unconstitutionality 5529/DF, which was ruled by the Supreme Court in 2021, resulting in the extinction of automatic patent extensions in Brazil. This documentary case study analyzes the effects of the judicial decision on patent applications and patents of interest for Productive Development Partnerships (PDP), investigating the progress of 90 patent applications related to 15 PDPs drugs of interest until Decembre 31, 2020. Variables for comparing the drug patent scenario with that of the PDPs were researched on the websites of the National Institute of Industrial Property, the Ministry of Health, ANVISA, and the Brazilian Medicines Market Regulation Chamber. Of 88 valid applications, 28 patents were granted, 17 of which had been extended to more than 20 years (24 years and 09 months average). The court decision resulted in a loss of over 68 years of monopoly, potentially opening alternatives for generic production. This resumption of the PDP policy should incorporate strategies to overcome patent barriers.

Resumo A covid-19 jogou luz sobre o impacto negativo da propriedade intelectual na saúde e deu nova relevância à Ação Direta de Inconstitucionalidade 5529/DF, que, acatada pelo Supremo Tribunal Federal em 2021, culminou na extinção da extensão automática de patentes no Brasil. Este estudo busca analisar o efeito do julgamento histórico da ADI 5529/DF sobre pedidos de patente e as patentes de interesse das Parcerias para Desenvolvimento Produtivo (PDP). Trata-se de um estudo com base em uma pesquisa documental de análise do andamento, até 31 de dezembro de 2020, de 90 pedidos de patente relacionados a 15 medicamentos objetos de PDP. Nos sites do Instituto Nacional de Propriedade Industrial, do Ministério da Saúde, da Anvisa e da Câmara de Regulação do Mercado de Medicamentos, foram pesquisadas variáveis para comparar o cenário patentário dos medicamentos com o das PDP. De 88 pedidos válidos, 28 patentes foram concedidas, das quais dezessete foram estendidas para mais de vinte anos (média de 24 anos e nove meses). A decisão do STF resultou em mais de 68 anos de monopólio perdidos, potencialmente desanuviando alternativas para a produção de genéricos no país. Neste momento de retomada das PDP, estratégias para a superação de barreiras patentárias deveriam ser incorporadas à política.

Abstract The COVID-19 pandemic has shed light on the negative impact of intellectual property on health and has given new relevance to the Direct Action of Unconstitutionality 5529/DF, which was ruled by the Supreme Court in 2021, resulting in the extinction of automatic patent extensions in Brazil. This documentary case study analyzes the effects of the judicial decision on patent applications and patents of interest for Productive Development Partnerships (PDP), investigating the progress of 90 patent applications related to 15 PDPs drugs of interest until Decembre 31, 2020. Variables for comparing the drug patent scenario with that of the PDPs were researched on the websites of the National Institute of Industrial Property, the Ministry of Health, ANVISA, and the Brazilian Medicines Market Regulation Chamber. Of 88 valid applications, 28 patents were granted, 17 of which had been extended to more than 20 years (24 years and 09 months average). The court decision resulted in a loss of over 68 years of monopoly, potentially opening alternatives for generic production. This resumption of the PDP policy should incorporate strategies to overcome patent barriers. COVID19 COVID 19 COVID-1 5529DF DF 5529 5529/DF 2021 Brazil PDP, , (PDP) 9 1 31 2020 Property Health ANVISA Chamber 8 2 granted 24 (2 0 average. average . average) 6 monopoly production barriers COVID1 COVID- 552 202 (PDP 3 ( 55 5

Resumo A covid-19 jogou luz sobre o impacto negativo da propriedade intelectual na saúde e deu nova relevância à Ação Direta de Inconstitucionalidade 5529/DF, que, acatada pelo Supremo Tribunal Federal em 2021, culminou na extinção da extensão automática de patentes no Brasil. Este estudo busca analisar o efeito do julgamento histórico da ADI 5529/DF sobre pedidos de patente e as patentes de interesse das Parcerias para Desenvolvimento Produtivo (PDP). Trata-se de um estudo com base em uma pesquisa documental de análise do andamento, até 31 de dezembro de 2020, de 90 pedidos de patente relacionados a 15 medicamentos objetos de PDP. Nos sites do Instituto Nacional de Propriedade Industrial, do Ministério da Saúde, da Anvisa e da Câmara de Regulação do Mercado de Medicamentos, foram pesquisadas variáveis para comparar o cenário patentário dos medicamentos com o das PDP. De 88 pedidos válidos, 28 patentes foram concedidas, das quais dezessete foram estendidas para mais de vinte anos (média de 24 anos e nove meses). A decisão do STF resultou em mais de 68 anos de monopólio perdidos, potencialmente desanuviando alternativas para a produção de genéricos no país. Neste momento de retomada das PDP, estratégias para a superação de barreiras patentárias deveriam ser incorporadas à política. covid19 covid 19 covid-1 5529DF DF 5529 que 2021 Brasil PDP . (PDP) Tratase Trata se andamento 3 2020 9 1 Industrial Saúde Medicamentos 8 válidos 2 concedidas média meses. meses meses) 6 perdidos país política covid1 covid- 552 202 (PDP 55 20 5

In hierdie artikel word verskeie metodes vir die definiëring van vroulike persoonsname in die Poolse leksikografie beskou en geanaliseer. Aandag word geskenk aan die tegnieke waarmee die resultate van die feminitiewe woordvormingskategorie wat in historiese en moderne woordeboeke opgeneem is, gedefinieer word. Dit het ten doel die bepaling van die beste metode om vroulike persoonsname vanuit die perspektief van die moderne gebruiker se behoeftes en beskouings van die wêreld, te definieer. strydig met die erkende definiëringsprak-tyke, is 'n vertroulike metode wat by die Navorsingsafdeling vir die Vorming van Vroulike Persoonsname by die Instituut van Poolse Studies aan die Wroclaw Universiteit, Pole, ontwikkel is, voorgestel. Dit het die grondslag vir die leksikografiese beskrywing wat in Slownik nazw zenskich polszczyzny (Woordeboek van Poolse vroulike naamwoorde) gebruik word, gevorm. In hierdie artikel word 'n goed-gefundeerde voorstel vir die definiëring van leksikale items uiteengesit waarin afgesien is van 'n verwysing na die generiese manlike, m.a.w. 'n sistemiese motivering tipies van die aanbieding van Poolse woordvorming.

This article considers and analyses various ways of defining feminine personal nouns in Polish-language lexicography. It deals with the techniques of defining products of the feminitive word-formation category which have been recorded in historical and modern dictionaries. It aims to determine the best way to define feminine personal nouns from the perspective of what the modern user needs and how they perceive the world. Against the recognised definition practices, a proprietary method developed at the Formation of Feminine Personal Nouns Research Section at the Institute of Polish Studies of Wroclaw University, Poland, has been proposed. It has become the basis for lexicographic description used in Slownik nazw zenskich polszczyzny (Dictionary of Polish Female Nouns). This article puts forward a rationale for defining lexical items in which a reference to the generic masculine, i.e. a systemic motivation typical of presentations of Polish word formation, has been abandoned.

Abstract. This work was originated from the increasing interest in several industries to implement voice based virtual assistant solutions powered by the Natural Language Processing field of study. This work is focused on the automotive industry Human Machine Interface related products, specifically the Instrument Panel. Nowadays people are constantly using virtual assistants like Google Assistant, Alexa, Cortana or Siri on their electronic devices. Furthermore, 31% of cars have a built-in virtual assistant, for example Ford uses Alexa, Merced es-Benz and Hyundai use Google Assistant, BMW and Nissan use Cortana, GM uses IBM Watson, Honda uses Hana and Toyota uses YUI. Apart from the proprietary solutions described earlier, there are also contemporary open-source generic solutions available on the market, such as Mycroft AI which stands out from other technologies due to ready to deploy, well documented, simple installation on a Linux PC or RPI SoC, and simple execution. This paper presents a way to use Mycroft AI as an alternative to add artificial intelligence-based voice assistance to applications in the automotive domain. The voice communication module presented here drives notifications related to three different entities: seat belt, fuel level and battery level, all of them are telltales present in any automotive Instrument Panel. Since the Mycroft AI design approach is based on Human Centered Design (HCD), the voice communication module presented here provides real user experience (UX) based design. As a conclusion, Mycroft AI demonstrates great potential as an alternative to add voice assistance to automotive industry Human Machine Interface related products. About future work, due to the fact that Mycroft AI is based on Python, there are many possibilities for connecting and expanding the voice communication module by using countless Python libraries in order to import and process any type of information, in any format or source, for example the information from communication technologies like CAN, LIN, Ethernet, MOST, GPS or any other device or technology in order to create comprehensive automotive solutions.

Resumen. Este trabajo se originó del creciente interés por parte de diferentes industrias para implementar soluciones de asistente virtual basado en voz impulsadas por el campo de estudio del Procesamiento del Lenguaje Natural. Este trabajo está enfocado en los productos relacionados a la Interfaz Humano Máquina de la industria automotriz, específicamente el Panel de Instrumentos. Hoy en día las personas usan constantemente asistentes virtuales como Google Assistant, Alexa, Cortana o Siri en sus dispositivos electrónicos. Más aún, 31% de los autos tienen un asistente virtual integrado, por ejemplo, Ford usa Alexa, Mercedes-Benz y Hyundai usan Google Assistant, BMW y Nissan usan Cortana, GM usa IBM Watson, Honda usa Hana y Toyota usa YUI. Aparte de las soluciones de marca registrada descritas anteriormente, también hay soluciones genéricas de código abierto contemporáneas disponibles en el mercado, tales como Mycroft AI que se hace notar por sobre otras tecnologías por características como listo para usar, bien documentada, instalación simple en una PC Linux o RPI SoC, y una ejecución simple. Este artículo presenta una manera de usar Mycroft AI como una alternativa para agregar inteligencia artificial basada en asistencia de voz a aplicaciones en el dominio automotriz. El módulo de comunicación de voz presentado aquí maneja notificaciones relacionadas a tres diferentes entidades: cinturón de seguridad, nivel de gasolina y nivel de batería, todos ellos son indicadores virtuales presentes en cualquier Panel de Instrumentos Automotriz. Dado que el enfoque de diseño de Mycroft AI se basa en Diseño Centrado en el Human (HCD), el módulo de comunicación por voz presentado aquí provee un diseño basado en experiencia de usuario (UX) real. Como conclusión, Mycroft AI demuestra gran potencial como una alternativa para agregar asistencia de voz a los productos relacionados a Interfaz Humano Máquina de la industria automotriz. Acerca del trabajo a futuro, debido al hecho que Mycroft AI está basado en Python, existen muchas posibilidades para conectar y expandir el módulo de comunicación por voz a través del uso de innumerables bibliotecas de Python para importar y procesar cualquier tipo de información, en cualquier formato o fuente, por ejemplo la información proveniente de tecnologías de comunicación tales como CAN, LIN, Ethernet, MOST, GPS o cualquier otro dispositivo o tecnología para crear soluciones automotrices integrales.

Resumen Introducción. La producción de alimentos regionales con identidad local y cultural se ha convertido en un negocio atractivo para los pequeños productores, porque permite que se comercialicen resaltando los ingredientes locales y el procesamiento tradicional que refleja el know-how de cada región. El queso de pasta hilada es un ejemplo. Objetivo. Identificar las características sensoriales y el nivel de agrado de quesos de pasta hilada costarricense (Palmito). Materiales y métodos. El proyecto se desarrolló en las instalaciones de la Universidad de Costa Rica, durante el 2015. Se utilizaron diecinueve muestras de queso Palmito costarricense. Catorce de ellas fueron fabricadas por productores artesanales y cinco por industriales. Se siguió la metodología de análisis descriptivo cuantitativo genérico (QDA) con diez jueces capacitados, que definieron veintiún atributos. Se realizó un análisis de clústeres (AHC) y análisis de componentes principales (PCA) para relacionar las muestras con sus atributos. La prueba de aceptación se realizó con cien consumidores. Se aplicaron técnicas de AHC del consumidor y mapeo preferencial externo para correlacionar los resultados de agrado con los obtenidos en el QDA. Resultados. Se obtuvieron diferencias significativas (p<0,05) entre muestras en el QDA para todos los atributos. Las muestras se agruparon en tres grupos de acuerdo con la similitud de su atributo. El PCA mostró un grupo, principalmente con quesos tradicionales, agrupados por sabor ácido, salado, firmeza, humedad y apariencia hilada, mientras que otro grupo, correspondiente a quesos almacenados en refrigeración, pasteurizados y sin pasteurizar, tuvieron una mayor intensidad de color amarillo, textura grasienta, suavidad y menor apariencia hilada. Un último grupo, compuesto por una muestra, presentó sabor a lechuga. Conclusión. Se concluyó, a través del mapeo preferencial externo, que a los consumidores les gusta la mayoría de los quesos Palmito industriales, pero prefieren los tradicionales con características como apariencia hilada y sabor cremoso.

Abstract Introduction. The production of regional food with local and cultural identity has become an attractive business for small-scale producers because it allows them to market their products highlighting local ingredients and traditional processing that reflects the know-how of each region. One example is Pasta filata cheese. Objective. To identify sensory characteristics and level of liking for Costa Rican Pasta filata cheeses (Palmito cheese). Materials and methods. The project was carried out at the facilities of the University of Costa Rica, during 2015. Nineteen samples of Costa Rican Palmito cheese were used, with fourteen of them being produced by artisanal producers and five by industrial producers. The methodology of Generic Quantitative Descriptive Analysis (QDA) was followed, with ten trained judges defining twenty-one attributes. Agglomerative Hierarchical Clustering (AHC) and Principal Component Analysis (PCA) were conducted to relate the samples to their attributes. Acceptance testing was performed with one hundred consumers. Consumer AHC and external preference mapping were applied to correlate the results of the liking with those of the QDA. Results. Significant differences (p<0,05) among samples were obtained in the QDA for all attributes. The samples were grouped into three clusters based on similarity attributes. The PCA showed one group, primarily consisting of traditional cheeses, clustered by attributes such as acid and salty flavor, firmness, moisture, and stringy appearance. Another group, corresponding to refrigerated, pasteurized, and unpasteurized cheeses, had a higher intensity of yellow color, greasy texture, softness, and less stringy appearance. A final group, composed of one sample, had a lettuce flavor. Conclusion. Through the external preference mapping, it was concluded that consumers like the majority of industrial Palmito cheeses, but they prefer traditional ones with characteristics such as stringy and creamy flavor.

Abstract Non-timber forest products are transcendental for the well-being of rural households, rural and suburban communities, they provide them with priority goods and services for their subsistence. The present work tries to identify the use of non-timber forest resources for the elaboration of handicrafts in the community of Malinalco, State of Mexico; as well as register the habitat where the resources come from and the legal and economic framework for the use of said resources. Through the ethnographic method, the instrument for obtaining the information, which was a questionnaire, was carried out and validated. Key informants were obtained, and interviews were conducted. During five months through semi-structured interviews with three artisans and 17 artisans from the community, a list of 11 different crafts made and marketed in the Malinalco community was obtained. Forest diversity was 15 species, 19 genera and 12 families; of which 4 taxa were identified at the generic level. The most used species are Agave sp. Crescentia alata Kunth and Jacaranda mimosifolia D. Don. The most representative families were Bignoniaceae and Asparagaceae. 43.9% were tree species, and 22% climbers, obtained from the low deciduous forest (58.3%) or from home gardens (18.75%). Regarding the parts used, 46.34% correspond to fruits and 17.07% to seeds. The knowledge about the use of flora in the elaboration of handicrafts allowed us to know the importance of the low deciduous forest and family gardens to obtain resources for the elaboration and commercialization of handicrafts in the community of Malinalco, State of Mexico.

Resumen Los productos forestales no maderables son trascendentales para el bienestar de las unidades domésticas campesinas, de comunidades rurales y suburbanas, les aportan bienes y servicios prioritarios para su subsistencia. El presente trabajo pretende identificar el uso de los recursos forestales no maderables para la elaboración de artesanías en la comunidad de Malinalco, Estado de México; así como registrar el hábitat de donde provienen los recursos y el marco legal y económico para el uso de dichos recursos. Por medio del método etnográfico, se realizó y validó el instrumento de obtención de la información que fue un cuestionario. Se obtuvieron los informantes clave y se realizaron las entrevistas. Durante cinco meses mediante entrevistas semiestructuradas a 03 artesanas y 17 artesanos de la comunidad, se obtuvo un listado de 11 diferentes artesanías elaboradas y comercializadas en la comunidad de Malinalco. La diversidad forestal fue de 15 especies, 19 géneros y 12 familias; de los cuales 4 taxa se identificaron a nivel genérico. Las especies más utilizados son; Agave sp., Crescentia alata Kunth y Jacaranda mimosifolia D. Don. Las familias con mayor representatividad fueron Bignoniaceae y Asparagaceae. El 52.63% fueron especies arbóreas, y el 42.10% herbáceas, obtenidas de la selva baja caducifolia (58.3%) o de huertos familiares (18.75%). Respecto a las partes utilizadas el 46.34% corresponde a frutos y el 17.07% a semillas. El conocimiento sobre el aprovechamiento de la flora en la elaboración de artesanías permitió conocer la importancia de la selva baja caducifolia y de los huertos familiares para la obtención de recursos para la elaboración y comercialización de artesanías en la comunidad de Malinalco, Estado de México.

Abstract Paper aims This paper compares the economic valuation (Intrinsic Cost or IC) of carbon dioxide emissions (carbon price) of the externality taxes (Kyoto Protocol) of the Argentine Production Chain (APC). Originality The experimental IC index and this novel combination allow incorporating objective (incremental) and subjective (acceptance, hierarchy and uncertainty) evaluation of the APC. This method is extended in this paper (to other operators). Research method The ICs are applied to attribute graphs in two scenarios (APC and society), that are obtained from the combination of Fuzzy Decision Making (FMD), Analytic Hierarchy Process (AHP) and PSO with the Algebraic (AP), Generic Hamacher (GHP and PHP) and Einstein (EP) products. Main findings (i) The coherency of the new ICs is demonstrated by mathematical and graphical analysis; (ii) The most demanding operators are the EP and HP. Implications for theory and practice It contributes to establish mechanisms for regulation of the APC. Intrinsic price Kyoto Protocol APC . (APC) incremental (incremental acceptance, acceptance (acceptance uncertainty operators. operators) society, society , society) FMD, FMD (FMD) AHP (AHP AP, AP (AP) GHP PHP (EP products i (i analysis ii (ii HP (FMD (AP

Abstract The elaboration of written texts has a key role in the preparation of future professionals in different disciplinary areas of university-level education. In these processes, teachers offer feedback the students´drafts, although they have scarce notion on how to do it. Despite the fact that it is a frequent activity, there is little evidence in Spanish as a first language that characterizes how feedback is offered in academic teaching contexts. Likewise, studies that indicate whether feedback presents variations according to the areas of knowledge and professional contexts for which it is trained in universities are less frequent. Various studies (Boud & Molloy, 2013; Hattie & Clarke, 2020; Winstone & Carles, 2021) reveal that attention is required in the way the teacher offers feedback. The aim of this research is to charactherize comments oriented to genre discourse (COG) offered by 9 teachers of 3 different disciplinary areas. These comments were provided to text produced by their students in a real-life learning context. The writing tasks were requested and evaluated within university training subjects. These teachers participated in training sessions de 10 hours each which oriented them on how to offer feedback. We collected 1976 written comments provided in the process of writing their task. We analyze them according to the mode ((order, question, suggestion, negative judgment, positive evaluation, indirect request and reflection) offered and disciplinary areas. Most of the writing products that teachers requested in their courses were for career preparation, followed by the development of research skills, one intended to demonstrate knowledge and one for writers’ self-expression. Such pedagogical objectives were expressed in seven specific genres. Of these, the "proposal", dedicated to formulating a plan to solve a typical situation of professional performance and solving a problem field, is the most transversal genre of all, since it is presented in the three disciplinary fields studied. Results of this research contribute to the characterization of how gender-adjustment written comments that university teachers from different disciplinary areas offer during their students' papers writing process in real teaching contexts. How the comment is expressed accounts for the dialogical relationship characteristics that are established between teachers and students through the feedback processes and the roles that are configured in the relationship. This could vary between disciplines, but may also be subject to the characteristics of the task and the individuals involved. The results indicate that teachers focused their comments to generic discursive aspects of the writing and the comment mode (order, question and suggestion) varies according the disciplinary areas.

Resumen En las diferentes áreas disciplinares de la formación universitaria, la elaboración de escritos juega un rol central en la formación de los futuros profesionales. En tales procesos los profesores ofrecen retroalimentación a los escritos, a pesar de que cuentan con poca noción acerca de cómo hacerlo. El objetivo de esta investigación es caracterizar los comentarios escritos de ajuste al género (CEAG) ofrecidos por nueve profesores de tres áreas disciplinares a escritos producidos por sus estudiantes en contextos de aprendizaje. Los profesores participaron de una capacitación que los orientó sobre cómo ofrecer comentarios. Se recabaron 1976 comentarios escritos ofrecidos a borradores de tareas de escritura, los que fueron analizados según el modo como se ofrecen y las áreas disciplinares. Los resultados indican que los profesores se focalizan en los aspectos discursivos genéricos del escrito y que el modo (orden, pregunta, sugerencia) de los comentarios varía según las áreas disciplinares.

Abstract Albendazole is an anthelmintic drug commonly used in parenchymal neurocysticercosis and cystic echinococcosis. The aim of this study was to explore whether disparities in the dissolution profiles of albendazole products lead to significant differences in pharmacokinetic parameters. Three generic products and the innovator were evaluated in vitro. Quality control tests were performed, and dissolution profiles were obtained according to the Mexican Pharmacopeia. Although all products passed the quality control tests, none of the generic products complied with the similarity factor (f 2). The product with the lowest f 2 value in respect to the reference was chosen for in vivo evaluation. The study was carried out in 12 healthy volunteers who received 400 mg of the generic or reference product according to a crossover design. No significant differences were found in Cmax and AUC for albendazole and its main metabolite, albendazole sulfoxide, between products. Two absorption peaks were observed in the pharmacokinetic profile, and a population (22%) with different absorption rates and delay time for the the second peak was found. Based on the results, due to the high variability in the absorption process the differences observed in vitro could not be observed in vivo. echinococcosis parameters performed Pharmacopeia 2. . 2) evaluation 1 40 design metabolite sulfoxide profile 22% 22 (22% results 4 (22 (2 (

Resumen Introducción. La caracterización y diversificación de los productos lácteos caprinos es muy importante para fortalecer a este incipiente sector productivo. Objetivo. Comparar las características fisicoquímicas y sensoriales de leches bovinas y caprinas enteras, descremadas y deslactosadas, así como de sus combinaciones. Materiales y métodos. En San José, Costa Rica, entre enero y diciembre del 2015 se evaluaron los contenidos de grasa (G), sólidos no grasos (SNG), acidez, proteína, densidad, pH, viscosidad y color de los tipos de leches citadas. Además, se efectuó un análisis sensorial descriptivo genérico y pruebas de agrado general. Resultados. La leche caprina entera presentó valores mayores de SNG, densidad y acidez, y menor pH, fue más blanca que la bovina y con una viscosidad similar. El proceso de deslactosado no afectó la viscosidad. Este factor interactuó con el tipo de leche, pero ninguno afectó los contenidos de grasa y proteína. Existió una interacción entre el tipo de leche y las modificaciones aplicadas para los parámetros de color. Los panelistas detectaron diferencias significativas para todos los atributos en los productos con excepción del aroma a ácido. Se estableció la presencia de tres conglomerados para la prueba de agrado compuestos por el 37,4 %, 28,8 % y 34,5 % de los jueces. El primero y segundo presentaron una preferencia por la leche entera y entera-deslactosada de vaca y, el tercero, por leche de cabra entera y entera-deslactosada de vaca y de cabra. El menor agrado general fue para las muestras tanto descremadas como deslactosadas bovinas y caprinas. Conclusiones. Los procesos de deslactosado y descremado modificaron la leche a nivel fisicoquímico, las leches de cabra con mayor agrado fueron las enteras y enteras-deslactosadas; el menor agrado general fue por las leches descremadas-deslactosadas en ambas especies.

Abstract Introduction. The characterization and diversification of goat dairy products is very important to strengthen this incipient productive sector. Objective. To compare the physicochemical and sensory characteristics of whole, skimmed and lactose-free cow and goat milks, as well as their combinations. Materials and methods. In San Jose, Costa Rica, between January and December of 2015, the contents of fat (F), non-fatty solids (NFS), acidity, protein, density, pH, viscosity, and color of the types of milk mentioned were evaluated. Also, a generic descriptive sensory analysis and a general liking test were carried out. Results. Whole goat milk presented higher values of NFS, density and acidity, and lower pH, being whiter than bovine milk, with a similar viscosity. The removal of lactose did not affect viscosity; this factor interacted with the type of milk, but did not affect the fat and protein contents. There was an interaction between the type of milk and the modifications made for the color parameters. The panelists detected significant differences for all the attributes in the products except for the acid aroma. The presence of three clusters was established for the liking test, composed by 37.4 %, 28.8 %, and 34.5 % of the judges. The first and second showed a preference for whole and whole lactose-free cow’s milk and the third for whole and whole-lactose-free cow’s and goat’s milk. The lowest overall liking was for both skimmed and lactose-free bovine and goat samples. Conclusions. The skimming and lactose removal process modified the milk at the physicochemical level, the goat milks with the highest liking were whole and whole lactose-free; the lowest overall liking was for those skimmed-lactose-free in both species.

Buyers and suppliers of healthcare products and services are more dependent on each other than ever before for the provision of scarce and unique resources, which highlights the need to implement supply chain sustainability practices. Firms controlling these resources hold excessive power over others. This study adopted resource dependence theory as a theoretical lens to explore the role of relationship power in supply chain sustainability practices between a South African private healthcare provider and its suppliers. The study employed a generic qualitative singlecase study design. Semi-structured interviews were used to collect data from 12 participants at various levels of the case organisation's hierarchy. The main findings revealed several types of environmental and social practice used in the supply chain of the private healthcare provider. Some of the environmental practices were effective waste management and recycling, while the social practices included supplier selection and periodic reviews. The healthcare provider exercised extensive power over its suppliers to implement these practices. By exploring the advantages and disadvantages of sustainability practices, the findings showed that relationship power acted as a driver of supply chain sustainability. Mutual commitment, continuous communication, and training support these practices. Healthcare managers must be aware of the importance of relationship power for supply chain sustainability practices implementation, and are advised to invest time and effort in building buyer-supplier relationships to aid sustainability. This study expands the literature on relationship power in supply chain sustainability practices in an underexplored developing country healthcare context.

Kopers en verskaffers van gesondheidsorgprodukte en -dienste is meer afhanklik van mekaar as tevore vir die voorsiening van skaars en unieke hulpbronne wat die implementering van voorsieningsketting-volhoubaarheidspraktyke aanspoor. Maatskappye wat hierdie hulpbronne beheer het buitensporige mag oor ander. Hierdie studie het hulpbronafhanklikheidsteorie as 'n teoretiese lens gebruik om die rol van verhoudingsmag in voorsieningsketting volhoubaarheidspraktyke tussen 'n Suid-Afrikaanse private gesondheidsorgverskaffer en sy leweransiers te ondersoek. Semi-gestruktureerde onderhoude was uitgevoer om data in te samel van 12 individue op verskeie vlakke van die gevallestudie onderneming se hierargie. Die studie het verskeie soorte omgewings- en sosiale praktyke geïdentifiseer. Van die geïdentifiseerde omgewingspraktyke is sluit effektiewe afvalbestuur en herwinning in, terwyl sosiale praktyke leweransier selektering en gereëlde hersienning ingesluit het. Die studie toon dat die groep mag uitoefen oor sy leweransiers om voorsieningskettingbestuur-volhoubaarheidspraktyke te implementeer. Die resultate van die studie dui aan dat verhoudingsmag 'n drywer van hierdie praktyke is. Gemeenskaplike getrouheid, voordurende kommunikasie, en opleiding ondersteun die praktyke. Gesondheidsorg bestuurders moet bewus wees van hoe belangrik verhoudingsmag vir hierdie praktyke se implementering is. Daar moet tyd belê word in die bou van koper-en-leweransier verhoudings om by te dra tot volhoubaarheid. Hierdie studie brei die literatuur rakende verhoudingskrag in voorsieningskettingvolhoubaarheidspraktyke uit in 'n onderontginde ontwikkelende land gesondheidsorgkonteks

Abstract The propose of this paper is to show that the guidelines established for the World Trade Organization, about of medicines, marginalize the access to those to the vulnerable population, because of to the high costs of the patent medicines and the retardment in the incorporation of generic products due; tariffs, profits, rents, and monopolistic control; the last two are based in the use of patents and the mechanisms that lengthen their validity. To do this, the main legal instruments regarding the human right to health were identified; the economic and legal changes about of intellectual property, because of globalization, to make visible the impact of the temporary monopoly in the production of medicines. The analytical method allowed to identify the numerals of the agreements that are violating the right to health that rule the member states of the World Trade Organization. Subsequently, certain elements are described to support the hypothesis about of the international instruments allow the monopolization of the production, distribution, and sale of medicines for the world population, prioritizing the profits of transnational companies over the right to health. Finally, the synthetic method allowed to establish some conclusions about the legal and statistical evidence, to strengthen the proposed hypothesis. In terms of originality, this work aims to show that economic rights have been prioritized over human rights. Among the findings, was found that pharmaceutical companies, taking advantage of legal vacuum, have strengthened, and lengthened the life of their monopolies.

Resumen El artículo pretende mostrar que los lineamientos establecidos por la Organización Mundial del Comercio, en materia de medicamentos, margina del acceso a estas a la población vulnerable, por los altos costos de las medicinas de patente y el retraso de la incorporación de los productos genéricos debido a aranceles, ganancias, rentas y control monopólico; los dos últimos se fundamentan en el uso de las patentes y los mecanismos que alargan su vigencia. Para ello, se identificaron los principales instrumentos jurídicos en torno al derecho humano a la salud y los cambios económicos y jurídicos en materia de propiedad intelectual, producto de la globalización, para visibilizar el impacto del monopolio temporal en la producción de medicinas. El método analítico permitió identificar los numerales de los acuerdos que vulneran el derecho a la salud que rigen a los Estados miembros de la Organización Mundial del Comercio. Posteriormente, se describen ciertos elementos para sostener la hipótesis de que los instrumentos internacionales señalados posibilitan la monopolización de la producción, distribución y venta de las medicinas para la población mundial, priorizando las utilidades de empresas transnacionales sobre el derecho a la salud. Por último, el método sintético permitió establecer algunas conclusiones sobre las evidencias jurídicas y estadísticas, para robustecer la hipótesis planteada. En cuanto a la originalidad, este trabajo pretende mostrar que se han priorizado los derechos económicos sobre los derechos humanos. Dentro de los hallazgos se encontró que las farmacéuticas, aprovechando los vacíos legales, han fortalecido y alargado la vida de sus monopolios.

ABSTRACT Background: In developing countries, particularly in Iraq, the use of generic medicines has been increasing in recent years, primarily as a cost-saving measure in healthcare provision. In the Iraqi market, famotidine tablets are available from different pharmaceutical companies. As a result, regular pre-marketing quality testing is required to check the quality and identify which product might safely substitute the innovator product in the event of the innovator brand’s unavailability or high cost. Objective: various quality control tests have been conducted to determine the Pharmaceutical Equivalence of the different generic and brands of Famotidine film-coated tablets marketed in Iraq. Materials and Methods: Four different samples of the most commonly available Famotidine 20 mg tablets in the Iraqi market were tested for drug contents, friability, and hardness. Additionally, the in-vitro drug release and kinetics were evaluated. Results: slight differences in the products’ content were found; however, they were within the acceptable requirement of British Pharmacopeia (BP) and The United States Pharmacopoeia (USP) 30, NF 25. Similarly, the friability and hardness were within the excellent range according to the B.P. and USP. The results of our study indicated that the tested brand (Famodin) and the three generic products (Famosam, Ulceran, and Famodar) of Famotidine tablets have a unique pattern of in-vitro release profiles. However, all the tested brands and generic pills complied with the USP specifications for the immediate release dosage forms except for Famosam. Release kinetic for the four tested products indicates first-order kinetic models. Conclusion: The findings revealed that nearly all of the tested Famotidine tablet brands and generics met the pharmacopeial requirements for oral tablets. As a result, if acquiring the innovative brand of famotidine tablets is difficult to obtain, healthcare providers may be advised to use the tested products instead.

RESUMEN Antecedentes: En los países en vías de desarrollo, especialmente en Irak, el uso de medicamentos genéricos ha aumentado en los últimos años, principalmente como medida de ahorro en la prestación de servicios sanitarios. En el mercado iraquí, los comprimidos de famotidina están disponibles en diferentes empresas farmacéuticas. Por ello, es necesario realizar periódicamente pruebas de calidad previas a la comercialización para comprobar la calidad e identificar qué producto podría sustituir con seguridad al producto innovador en caso de que éste no esté disponible o tenga un coste elevado. Objetivo: se han realizado varias pruebas de control de calidad para determinar la Equivalencia Farmacéutica de los diferentes genéricos y marcas de Famotidina comprimidos recubiertos con película comercializados en Irak. Materiales y métodos: Se analizaron cuatro muestras diferentes de los comprimidos de 20 mg de Famotidina más comunes en el mercado iraquí para determinar el contenido de fármaco, la friabilidad y la dureza. Además, se evaluó la liberación in-vitro del fármaco y su cinética. Resultados: Se encontraron ligeras diferencias en el contenido de los productos; sin embargo, estaban dentro de los requisitos aceptables de B.P. y de la Farmacopea de Estados Unidos (USP) 30, NF 25. Así mismo, la friabilidad y la dureza estaban dentro del rango excelente según la B.P. y la USP. Los resultados de nuestro estudio indicaron que la marca probada (Famodin) y los tres productos genéricos (Famosam, Ulceran y Famodar) de comprimidos de famotidina tienen un patrón único de perfiles de liberación in-vitro. Sin embargo, todas las marcas y los comprimidos genéricos probados cumplieron con las especificaciones de la USP para las formas farmacéuticas de liberación inmediata, excepto Famosam. La cinética de liberación de los cuatro productos probados indica modelos cinéticos de primer orden. Conclusiones: Los resultados revelaron que casi todas las marcas y genéricos de comprimidos de Famotidina probados cumplían los requisitos farmacopeicos para los comprimidos orales. En consecuencia, si resulta difícil adquirir la marca innovadora de comprimidos de famotidina, se puede aconsejar a los profesionales sanitarios que utilicen los productos probados en su lugar.

Abstract The aim of this work was to assess if the commercially available Fluconazole drug products (Reference, Generic and Similar) would meet the biowaiver criteria from Food and Drug Administration (FDA) and Brazilian Agency for Health Surveillance (ANVISA) agencies. All formulations were evaluated considering the dissolution profile carried out in Simulated Gastric Fluid (SGF) pH 1.2, Acetate Buffer (AB) pH 4.5 and Simulated Intestinal Fluid (SIF) pH 6.8. The results demonstrated that all formulations fulfilled the 85% of drug dissolved at 30 min criterion in SGF pH 1.2. However, in AB pH 4.5 and SIF pH 6.8, some formulations, including the comparator, did not achieve this dissolution percentage. The discrepant dissolution profiles also failed the ƒ2 similarity factor analysis, since none of the formulations showed values between 50 and 100 in the three dissolution media. Comparative dissolution profiles were not similar, considering that the main issues concerning the dissolution were evidenced for the comparator product. Hence, a revision in the regulatory norms in order to establish criteria to switch the comparator could result in an increased application of drugs based on biowaiver criteria.

Abstract This work aims to ascertain the comprehensiveness of dissolution tests for oral suspensions registered in Brazil and the USA. After consulting literature since 1994, a paucity of information about dissolution methods for suspensions was detected. It makes it difficult to establish the most appropriate test parameters. In January, 2019, there were 46 drugs registered in Anvisa (Brazil) as oral suspension, being 47 reference, 173 generic and 114 interchangeable similar (IS) medicines; while in the USA, 90 drugs were registered as oral suspension by FDA, 235 Abreviatted New Drug Application and 111 New Drug Application medicines. Out of 46 and 90, only six and 15 drugs as oral suspension had a pharmacopeial dissolution test, corresponding to 70 (20.9%) and 82 (23.7%) products in Brazil and the USA, respectively. Dissolution studies were found for 17 drugs as oral suspension in the non-compendial literature. Dissolution test conditions were established to few marketable oral suspension drugs, most of which are BCS class II or IV. Thus, investing in dissolution studies could subsidize the registration of these products by regulators, especially for generic and IS drugs, by comparing dissolution profiles, and predicting their in vivo behavior to avoid exposure of healthy individuals to clinical research.