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Sanitary Regulation of Pharmaceutical Products in Mexico （Sanitary Registration-Board Arrangement-Patent）-Monoclonal Antibody Case Study

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Journal of Pharmacy and Pharmacology 2018年第8期6卷 772-781页

作者： Patricia Parra Cervantes Felix Lugo Trejo ramón soto vázquez Alma Herrera Márquez Faculty of Higher Education "Zaragoza" UNAM. col. Ejército de oriente CP09230 Cd de México México

The Federal Commission for Protection against Health Risks in Mexico （COFEPRIS） is responsible for the regulation and health promotion of the production, commercialization, import, export, publicity or involuntary exposure of medicines and technologies for health. For its part, the Mexican Institute of Industrial Property （IMPI） is a decentralized public body with legal personality, own property and legal authority to administer the industrial property system in our country. In the year 2000, on September 19, the official journal published the linking of patents related to allopathic medicines and the sanitary registry. Objectives： To publicize the process of linking the Sanitary-Patent Registry as a case study to delimit the scope of the new pharmaceutical products. Methodology： Request the information to COFEPRIS for the registration of a new pharmaceutical product; Establish flow diagrams for the registration of： innovative products, generic products, biotech products and bio similar products; Integrate the documents in the dossier of the pharmaceutical product for sanitary registration; Elaborate sworn letter of non-invasion of patents and study of patents; Submit the Health Registry; Intergovernmental consultation. Sanitary Registry Results： Search of patents in databases to elaborate state of the art, to write letter under protest to say truth that is not invading any patent, when developing a composition of cetuximab, as generic product since the patent molecule expired in 2016 and 11 patents related to compositions, preparations and finished product preparation processes. Conclusions： COFEPRIS will determine through intergovernmental consultation with the IMPI whether or not a patent is invaded, according to the case it will grant the registration or send the corresponding prevention for cetuximab, in case that invading can also be a refusal of grant.

关键词： Sanitary registration patents patent-health registration link cetuximab.

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Development and validation of Proximal Chemistry Analytical Procedure in Semi-automated Equipment

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Journal of Pharmacy and Pharmacology 2018年第8期6卷 782-789页

作者： Patricia Parra Cervantes M. Tonantzin Rios Rodríguez Janet Edith Santamaría víquez ramón soto vázquez Joaquin Tlatempa López Faculty of Higher Education "Zaragoza" Batalla 5 de mayo S/n Ejército de Oriente CP09230 CDMX México RPL Constatacion S. de R.L. de C.v. Oriente 251A #25 Col. Agrícola Oriental Delegación Iztacalco CP 08500 CDMX México

The proximal chemical analysis （AQP） includes 5 fundamental tests, which are： determination of crude protein, determination of crude fiber, determination of humidity, determination of ashes and determination of fat. This last determination can be made in two different ways, which will depend on the type of sample being treated, as well as the amount of fat expected to be obtained in the food to be analyzed. For foods with low amounts of fat the hydrolysis technique is used, which is divided into 3 phases. All the methods before being taken to the daily practice in a laboratory of food analysis either internal control, verification or third authorized must be validated, in order to obtain consistent, robust and reliable results. In those cases in which the method that will be tested differs with the method that is reported in the literature, a comparison of both methods should be made in order to ensure that both are compatible and the results will be equally reliable. In the validation, the acceptance parameters will be established for each one of the tests that are carried out in it, while at the end of it the acceptance criteria for the general method will be established. The objective of this work was to carry out the development of analytical methodology that was validatable in order to reduce analysis time by using semi-automated equipment. In the case of semi-automated equipment, this comparison of methods is carried out, as it was the case of the analysis of fat with hydrolysis, which used a hydrolysis unit and the extraction equipment using samples of finished food for animal consumption. The results obtained in the validation using the traditional method correspond to a Cv less than 2%, while the results obtained using semi-automated equipment correspond to a Cv less than 2% for the case of fat determination with hydrolysis.

关键词： validation analytical methods semiautomatic animal feed.

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Dendritic spine degeneration:a primary mechanism in the aging process

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neural Regeneration Research 2025年第6期20卷 1696-1698页

作者： Gonzalo Flores Leonardo Aguilar-Hernández Fernado García-Dolores Humberto nicolini Andrea Judith vázquez-Hernández Hiram Tendilla-Beltrán Instituto de Fisiología Benemérita Universidad Autónoma de Puebla(BUAP)PueblaMexico Instituto de Ciencias Forenses(InCIFO) Tribunal Superior de Justicia de la Ciudad de México(TSJCDMX).Mexico CityMexico Instituto nacional de Medicina Genómica(InMEGEn) Mexico CityMexico

Recent reports suggest that aging is not solely a physiological process in living beings;instead, it should be considered a pathological process or disease(Amorim et al., 2022). Consequently, this process involves a wide range of factors, spanning from genetic to environmental factors, and even includes the gut microbiome(GM)(Mayer et al., 2022). All these processes coincide at some point in the inflammatory process, oxidative stress, and apoptosis, at different degrees in various organs and systems that constitute a living organism(Mayer et al., 2022;AguilarHernández et al., 2023).

关键词： aging process stress

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Impacts of PI3K/protein kinase B pathway activation in reactive astrocytes: from detrimental effects to protective functions

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neural Regeneration Research 2025年第4期20卷 1031-1041页

作者： ramón Pérez-núñez María Fernanda González Ana María Avalos Lisette Leyton Cellular Communication Laboratory Programa de Biología Celular y MolecularCenter for Studies on ExerciseMetabolism and Cancer(CEMC)Instituto de Ciencias Biomédicas(ICBM)Facultad de MedicinaUniversidad de ChileSantiagoChile Advanced Center for Chronic Diseases(ACCDiS) Faculty of Chemical and Pharmaceutical Sciences&Faculty of MedicineUniversidad de ChileSantiagoChile Instituto de Ciencias Biomédicas Facultad de Ciencias de la SaludUniversidad Autónoma de ChileSantiagoChile

Astrocytes are the most abundant type of glial cell in the central nervous *** injury and inflammation,astrocytes become reactive and undergo morphological and functional *** on their phenotypic classification as A1 or A2,reactive astrocytes contribute to both neurotoxic and neuroprotective responses,***,this binary classification does not fully capture the diversity of astrocyte responses observed across different diseases and *** analysis has revealed that reactive astrocytes have a complex landscape of gene expression profiles,which emphasizes the heterogeneous nature of their *** actively participate in regulating central nervous system inflammation by interacting with microglia and other cell types,releasing cytokines,and influencing the immune *** phosphoinositide 3-kinase(PI3K)/protein kinase B(AKT)signaling pathway is a central player in astrocyte reactivity and impacts various aspects of astrocyte behavior,as evidenced by in silico,in vitro,and in vivo *** astrocytes,inflammatory cues trigger a cascade of molecular events,where nuclear factor-κB serves as a central mediator of the pro-inflammatory ***,we review the heterogeneity of reactive astrocytes and the molecular mechanisms underlying their *** highlight the involvement of various signaling pathways that regulate astrocyte reactivity,including the PI3K/AKT/mammalian target of rapamycin(mTOR),αvβ3 integrin/PI3K/AKT/connexin 43,and notch/PI3K/AKT *** targeting the inactivation of the PI3K/AKT cellular signaling pathway to control reactive astrocytes and prevent central nervous system damage,evidence suggests that activating this pathway could also yield beneficial *** dual function of the PI3K/AKT pathway underscores its complexity in astrocyte reactivity and brain function *** review emphasizes the importance of employing astrocyte-exclusive models to underst

关键词： inflammation integrins neuroprotective neurotoxic phosphatidylinositol 3-kinase reactive astrocytes signal transduction Thy-1(CD90)

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Weathering Trump2.0

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China Today 2025年第1期74卷 20-21页

作者： AUGUSTO soto Dialogue with China Project in Barcelona Spain

While the 47^(th) *** has declared a trade war on all nations,China has the strength to get ahead despite the complex rivalry.“History doesn’t repeat itself,but it often rhymes.”This saying by celebrated American writer Mark Twain,a contemporary of the American Civil War(1861-1865)and the Crimean War(1853-1856),resonates uncannily once again as Donald Trump takes charge in the United States.

关键词： Trump saying contemporary

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Spectrophotometric determination of the formation constants of Calcium(Ⅱ) complexes with 1,2-ethylenediamine,1,3-propanediamine and 1,4-butanediamine in acetonitrile

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Green Energy & Environment 2017年第1期2卷 51-57页

作者： Jacqueline González González Mónica nájera-Lara varinia López-ramírez Juan Antonio ramírez-vázquez José J.n.Segoviano-Garfias Programa de Maestría en Biociencias División de Ciencias de la Vida (DICIVA) Universidad de Guanajuato Campus Irapuato-Salamanca Colegio del nivel Medio Superior de Salamanca(EnMS) Departamento de Ingeniería Bioquímica Instituto Tecnológico Superior de Irapuato (ITESI) Departamento de Ciencias Ambientales División de Ciencias de la Vida (DICIVA) Universidad de Guanajuato Campus Irapuato-Salamanca

In this work, with the purpose to explore the coordination chemistry of calcium complexes which could work as a partial model of manganese-calcium cluster, a spectrophotometric study to evaluate the stability of the complexes: Calcium(Ⅱ)-1,2-ethylendiamine, Calcium(Ⅱ)-1,3-propanediamine and Calcium(Ⅱ)-1,4-butanediamine in acetonitrile, were carried on. By processing the spectrophotometric data with the HypSpec program allows the determination of the formation constants. The logarithmic values of the formation constants obtained for Calcium(Ⅱ)-1,2-ethylendiamine, Calcium(Ⅱ)-1,3-propanediamine and Calcium(Ⅱ)-1,4-butanediamine were log β_(110) = 4.69, log β_(110)= 5.25 and log β_(110) = 4.072, respectively.

关键词： Calcium(Ⅱ)complexes Solution equilibria Artificial photosynthesis Absorbance molar Speciation

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numerical Simulation of Bed Load and Suspended Load Sediment Transport Using Well-Balanced numerical Schemes

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Communications on Applied Mathematics and Computation 2023年第2期5卷 885-922页

作者： J.C.González-Aguirre J.A.González-vázquez J.Alavez-ramírez R.Silva M.E.vázquez-Cendón División Acádemica de Ciencias Básicas Universidad Juárez Autónoma de TabascoCarr.Cunduacán-Jalpa de Mendéz KM.1CP 86690CunduacánTabascoMexico Universidad Autónoma Metropolitana-Unidad Iztapalapa Av.San Rafael Atlixco no.186Mexico CityMexico Instituto de Ingeniería Universidad Nacional Autónoma de México04510 Mexico CityMexico Departamento de Matemática Aplicada Universidade de Santiago de Compostela15706 Santiago de CompostelaSpain

Sediment transport can be modelled using hydrodynamic models based on shallow water equations coupled with the sediment concentration conservation equation and the bed con-servation *** complete system of equations is made up of the energy balance law and the Exner *** numerical solution for this complete system is done in a seg-regated ***,the hyperbolic part of the system of balance laws is solved using a finite volume *** ways to compute the numerical flux have been considered,the Q-scheme of van Leer,the HLLCS approximate Riemann solver,and the last one takes into account the presence of non-conservative products in the *** discretisation of the source terms is carried out according to the numerical flux *** the second stage,the bed conservation equation is solved by using the approximation computed for the system of balance *** numerical schemes have been validated making comparisons between the obtained numerical results and the experimental data for some physical *** numerical results show a good agreement with the experimental data.

关键词： Sediment transport Suspended load Bed load Finite volume method numerical simulation Well-balanced schemes

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Bedrock outcropping in the accumulation zone of the largest glacier in Mexico(Glaciar norte of Citlaltépetl),as evidence of a possible accelerated extinction

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Journal of Mountain Science 2023年第2期20卷 338-354页

作者： soto víctor Colegio de Geografía Facultad de EconomíaUniversidad VeracruzanaAv.Xalapa s/nObrero Campesina91020XalapaVer.México

The highest volcano in Mexico,at the same time the third largest mountain in north America(Citlaltépetl,5610 m a.s.l.),is home to the largest glacier in the *** of the extinction of the Popocatépetl glacier(5500 m a.s.l.)caused by eruptive activity,and the almost disappearance of the Iztaccíhuatl glaciers(5220 m a.s.l.)due to the lower elevation of the mountain,the Glaciar norte of Citlatépetl has been the only glacier that has shown a certain degree of stability as a response to the altitude in which it is ***,as occurs in almost all glaciers on the planet,the retreat of its glacier terminus has been ***,during the last years the thickness of its upper part began to decrease rapidly until its bedrock was exposed for the first time in *** to its ecosystem importance and because it is the main glacier in Mexico,as well as the only one in the world located at latitude 19°n,in this work its current dimensions are updated,as well as the local climatology that governs the current state of the glacier is pointed *** study was based on the analysis of high-resolution Sentinel-2 optical images,as well as through Sentinel-1 SAR images,with the support of climatological information from the study ***,the outcropping of the bedrock in the accumulation zone and the consequent horizontal retreat of the upper part of the glacier are documented;at the same time,the decrease in the thickness of the ice along it is *** rocky outcrop in the accumulation zone suggests that the flow dynamics of the ice towards the ablation zone will be considerably less,accelerating the retreat of the glacier ***,the ascent of the glacial front to 5102 m *** the modelled altitude of the equilibrium line to 5276 m *** reported as a warning signal in terms of snow catchment and mass balance;likewise,the decrease of 23%of its surface is also indicated regarding the surface reduction monitoring that has been done

关键词： Bedrock outcrop Citlaltépetl glacier Glacial accumulation zone Glacier retreat Glacial thickness

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Semantic Segmentation of Lumbar vertebrae Using Meijering U-net(MU-net)on Spine Magnetic Resonance Images

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Computer Modeling in Engineering & Sciences 2025年第1期142卷 733-757页

作者： Lakshmi S v v Shiloah Elizabeth Darmanayagam Sunil Retmin Raj Cyril Department of Computer Science and Engineering College of Engineering GuindyAnna UniversityChennai600025India Department of Information Technology Madras Institute of TechnologyAnna UniversityChrompetChennai600044India

Lower back pain is one of the most common medical problems in the world and it is experienced by a huge percentage of people *** to its ability to produce a detailed view of the soft tissues,including the spinal cord,nerves,intervertebral discs,and vertebrae,Magnetic Resonance Imaging is thought to be the most effective method for imaging the *** semantic segmentation of vertebrae plays a major role in the diagnostic process of lumbar *** is difficult to semantically partition the vertebrae in Magnetic Resonance Images from the surrounding variety of tissues,including muscles,ligaments,and intervertebral discs.U-net is a powerful deep-learning architecture to handle the challenges of medical image analysis tasks and achieves high segmentation *** work proposes a modified U-net architecture namely MU-net,consisting of the Meijering convolutional layer that incorporates the Meijering filter to perform the semantic segmentation of lumbar vertebrae L1 to L5 and sacral vertebra ***-colour mask images were generated and used as ground truth for training the *** work has been carried out on 1312 images expanded from T1-weighted mid-sagittal MRI images of 515 patients in the Lumbar Spine MRI Dataset publicly available from Mendeley *** proposed MU-net model for the semantic segmentation of the lumbar vertebrae gives better performance with 98.79%of pixel accuracy(PA),98.66%of dice similarity coefficient(DSC),97.36%of Jaccard coefficient,and 92.55%mean Intersection over Union(mean IoU)metrics using the mentioned dataset.

关键词： Computer aided diagnosis(CAD) magnetic resonance imaging(MRI) semantic segmentation lumbar vertebrae deep learning U-net model

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Assessment of Mg(OH)_(2)/TiO_(2) coating in the Mg-Ca-Zn alloy for improved corrosion resistance and antibacterial performance

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Journal of Magnesium and Alloys 2023年第1期11卷 361-378页

作者： Leonardo Hernández Jesús ramón-Sierra Montserrat Soria-Castro Ángel Bacelis Geonel Rodríguez-Gattorno Elizabeth Ortiz-vázquez Gloria Acosta Applied Physics Department Center for Research and Advanced Studies of the National Polytechnic Institute(CINVESTAV-IPN)Carr.Ant.a Progreso km.6C.P.97310MeridaYucatanMexico Tecnológico nacional de México/Instituto Tecnológico de Mérida.Av.Tecnológico s/n Km.4.5 ant.Carr.Mérida-Progreso C.P.97118MéridaYucatánMéxico Facultad de Química Universidad Nacional Autónoma de México(UNAM)Av.Universidad 3000C.P.04510CoyoacánCDMXMéxico

The high activity of metallic magnesium and alloys limits its potential in biomedical applications;in recent years,extensive efforts have been devoted to modulating this *** this work,we present Mg(OH)_(2) and TiO_(2)barrier coatings to reduce the degradation of magnesium alloy(Mg-Ca-Zn)*** coatings were deposited by the anodization method and the spin-coating technique,*** anodized layer was coated with TiO_(2)generated from the hydrolysis of 3%weight of TTIP(Ti[OCH(CH_(3))_(2)]_(4),Titanium(Iv)isopropoxide)in 2-Propanol deposited by the spin-coating *** the degradation in Ringer’s solution by electrochemical impedance spectroscopy and OCP revealed a 98%reduction in pittings in uncoated samples after 14 days of *** p H measurements revealed that the TiO_(2)coating reduced the alkalization of the physiological environment,keeping the pH at 6.0 *** vitro studies of two types of bacteria(*** and ***)exhibited zones of inhibition in the agar and activity bactericidal(kill time test).The mechanisms behind the improved degradation resistance and enhanced antibacterial activity are presented and discussed *** modification with Mg(OH)_(2)/TiO_(2)coatings is a promising strategy to control the biodegradation of magnesium implants for bone regeneration.

关键词： Magnesium alloy EIS Mg(OH)_(2) TiO_(2) Antibacterial coatings

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