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This research is based on three fundamental aspects of successful biosimilar development in the challenging biopharmaceutical market. First, biosimilar regulations in eight selected countries: Japan, South Korea, the United States, Canada, Brazil, Argentina, Australia, and South Africa, represent the four continents. The regulatory aspects of the countries studied are analyzed, highlighting the challenges facing biosimilars, including their complex approval processes and the need for standardized regulatory guidelines. There is an inconsistency depending on whether the biosimilar is used in a developed or developing country. In the countries observed, biosimilars are considered excellent alternatives to patent-protected biological products for the treatment of chronic diseases. In the second aspect addressed, various analytical AI modeling methods (such as machine learning tools, reinforcement learning, supervised, unsupervised, and deep learning tools) were analyzed to observe patterns that lead to the prevalence of biosimilars used in cancer to model the behaviors of the most prominent active compounds with spectroscopy. Finally, an analysis of the use of active compounds of biosimilars used in cancer and approved by the FDA and EMA was proposed.
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This article presents a groundbreaking perspective on carotenoids, focusing on their innovative applications and transformative potential in human health and medicine. Research jointly delves deeper into the bioactivity and bioavailability of carotenoids, revealing therapeutic uses and technological advances that have the potential to revolutionize medical treatments. We explore pioneering therapeutic applications in which carotenoids are used to treat chronic diseases such as cancer, cardiovascular disease, and age-related macular degeneration, offering novel protective mechanisms and innovative therapeutic benefits. Our study also shows cutting-edge technological innovations in carotenoid extraction and bioavailability, including the development of supramolecular carriers and advanced nanotechnology, which dramatically improve the absorption and efficacy of these compounds. These technological advances not only ensure consistent quality but also tailor carotenoid therapies to each patient's health needs, paving the way for personalized medicine. By integrating the latest scientific discoveries and innovative techniques, this research provides a prospective perspective on the clinical applications of carotenoids, establishing a new benchmark for future studies in this field. Our findings underscore the importance of optimizing carotenoid extraction, administration, bioactivity, and bioavailability methods to develop more effective, targeted, and personalized treatments, thus offering visionary insight into their potential in modern medical practices.
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Disponibilidade Biológica , Carotenoides , Carotenoides/química , Carotenoides/farmacocinética , Humanos , Doenças Cardiovasculares/tratamento farmacológico , Neoplasias/tratamento farmacológico , Neoplasias/metabolismo , Animais , Degeneração Macular/tratamento farmacológico , Degeneração Macular/metabolismoRESUMO
This research reviews the phenomenon of extractive deforestation as a possible trigger for cascade reactions that could affect part of the forest ecosystem and its biodiversity (surface, aerial, and underground) in tropical, subtropical, and boreal forests. The controversy and disparities in criteria generated in the international scientific community around the hypothesis of a possible link between "mother trees" and mycorrhizal networks in coopetition for nutrients, nitrogen, and carbon are analyzed. The objective is to promote awareness to generate more scientific knowledge about the eventual impacts of forest extraction. Public policies are emphasized as crucial mediators for balanced sustainable development. Currently, the effects of extractive deforestation on forest ecosystems are poorly understood, which requires caution and forest protection. Continued research to increase our knowledge in molecular biology is advocated to understand the adaptation of biological organisms to the new conditions of the ecosystem both in the face of extractive deforestation and reforestation. The environmental impacts of extractive deforestation, such as the loss of biodiversity, soil degradation, altered water cycles, and the contribution of climate change, remain largely unknown. Long-term and high-quality research is essential to ensure forest sustainability and the preservation of biodiversity for future generations.
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INTRODUCTION: Biosimilars are gaining popularity in Latin America (LA). The biosimilars market is expected to grow rapidly over the next decade as a cost-effective alternative to expensive patented biologics. The drivers for the growing demand include needs for affordable health care, the prevalence of chronic diseases, expiration of patents for numerous biologic medicines and the advent of artificial intelligence (AI). Countries such as Argentina, Brazil and Mexico have implemented regulatory frameworks for the approval of biosimilars as well as for investment in local manufacturing capacity, sale, and distribution. Some LA countries face challenges related to low quality institutional frameworks and deficient public policies for regulatory harmonization of these medicines. AREAS COVERED: The aim of this article is to analyze the broad window of opportunity for biosimilars in LA (Brazil, Mexico and Argentina) in the next decade, considering their regulations and institutional quality, as well as an affordable cost for patients with chronic diseases and highlight the biosimilars approved in the three countries studied. Likewise, the future contribution of AI in the drug R&D process is considered. EXPERT OPINION: Preparing the next decade of biosimilars in LA will involve improving international regulatory frameworks, institutional quality, investments and capacity in R&D (competencies, infrastructure, and AI).
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Medicamentos Biossimilares , Humanos , Medicamentos Biossimilares/uso terapêutico , América Latina/epidemiologia , Inteligência Artificial , Doença CrônicaRESUMO
The research evaluated the opinion of those in charge of the administrative management of the logistics and supply chain of medical and pharmaceutical stocks of health care centers in the north of Chile and a potential improvement of their operations through the use of artificial intelligence (AI). The identification of the problem arose from the empirical analysis, where serious deficiencies in the manual handling and management of the stock of medicines and hospital supplies were evidenced. This deficiency does not allow a timely response to the demand of the logistics and supply chain, causing stock ruptures in health centers. Based on this finding, we asked ourselves how AI was observed as the most efficient tool to solve this difficulty. The results were obtained through surveys of personnel in charge of hospital and pharmacy supplies. The questions focused on the level of training, seniority in positions related to the problem, knowledge of regulations, degree of innovation in the procedures used in logistics and supply chain and procurement. However, a very striking fact was related to the importance of the use of AI, where, very surprisingly, 64.7% considered that it would not help to reduce human errors generated in the areas analyzed.
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Academias de Ginástica , Assistência Farmacêutica , Humanos , Inteligência Artificial , Chile , Instalações de SaúdeRESUMO
The convergence of different theories (ie, catch-up effect and windows of opportunities) allows for the interpretation of different "technological innovation gaps" in Chile's biomedical industry. It is common knowledge that Chile has always had an economy almost exclusively based on services, commodities, and mainly in the exploitation of natural resources with low value added. The literature confirms that countries that concentrate their economies on the knowledge, research, development, and commercialization of technology and innovation have a better and more stable growth rate in the medium and long run. The "Asian Tigers" are a good example of this. Analyzing the technological gaps that affect the Chilean biomedical industry, it is possible to find windows of opportunities to catch up. This could allow the country to take its knowledge, skills, and capabilities further, thus enabling Chile to not just depend on its unpredictable natural resources. For the first time, a quantitative diagnosis of the Chilean biomedical industry was made. This study considered the Chilean biomedical industry and its innovation and entrepreneurship environment, taking into account its productive capacities and its potential to make progress in technological innovation and, as a result, dramatically reducing technological gaps through windows of opportunities.
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Tecnologia Biomédica , Difusão de Inovações , Chile , Empreendedorismo , Humanos , Inquéritos e QuestionáriosRESUMO
The development of biological products has experienced continuous growth over the past three decades. The expiration of patent protection for many biological medicines has led to the development of biosimilars in many countries around the world. This paper reviews the literature on biosimilar drugs and covers their therapeutic status, clinical trials, approved biosimilars, and regulatory guidelines in Japan, South Korea, and Malaysia. The literature suggests that biosimilars are comparable but not identical to the reference product. They are not a generic version of an innovative product and do not ensure therapeutic equivalence. Biosimilars present more challenges than conventional generics and their marketing approval is also much more complicated. Guidelines for biosimilars were published in Japan in July 2009 by the Ministry of Health, Labour and Welfare (MHLW), in South Korea in March 2009 by the Ministry of Food and Drug Safety (MFDS), and in Malaysia in July 2008 by the National Pharmaceutical Control Bureau (NPCB).