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Pharmacokinetics and Bioequivalence Evaluation of Two Rosuvastatin Calcium 20 mg Tablets: A Single Oral Dose, Randomized-Sequence, Open-Label, Two-Period Crossover Study in Healthy Volunteers under Fasting Conditions

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Journal of Biosciences and Medicines 2024年第6期12卷 230-243页

作者： evelyn pena Alfredo Inatti José Gregorio Chacón Department of Clinical Research Industrias Biocontrolled C.A. Caracas Venezuela

Objectives: To compare the rate and extent of absorption of Racor® 20 mg (Rosuvastatin calcium 20 mg) tablet of Laboratorios Leti, S.A.V., with Crestor® 20 mg (Rosuvastatin calcium 20 mg) tablet of AstraZeneca, UK Limited in healthy adult human subjects under fasting conditions. Method: This was an open label, analyst blind, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study in healthy, adult, human subjects under fasting condition. Twenty-four (24) subjects were planned as per the protocol and all subjects completed both periods of the study. The concentrations of Rosuvastatin in plasma were quantitated using a validated LC-MS/MS method of analysis and plasma levels were submitted for statistical analysis. Cmax, AUC0-t, AUC0-∞, Tmax, t1/2, Kel (hrs-1), percent AUC extrapolated [100 * (AUC0-∞ - AUC0-t)/AUC0-∞] (AUC_%Extrapobs) were calculated for rosuvastatin in plasma using SAS® version 9.1.3, SAS Institute. Inc. ***. ANOVA, 90% confidence interval using Schuirmann’s two one-sided test for bioequivalence, power and ratio analysis, for lntransformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ were computed and reported for Rosuvastatin in plasma for BE. Results: Data showed that 90% confidence intervals for the test/reference geometric mean ratios (GMR) of Cmax (95.01 - 112.66), AUC0-t (93.38 - 111.67) and AUC0-∞ (93.65 - 111.29) were within the BE (80% - 125%) acceptance range. Conclusions: Two products formulation, reference (R) Crestor® (rosuvastatin calcium) of AstraZeneca and test (T), Racor® (rosuvastatin calcium) of Laboratorios Leti S.A.V., with a single dose of 20 mg, under fasting conditions were bioequivalent. No severe, serious or unexpected adverse events (AEs) were reported in this study.

关键词： Bioequivalence Rosuvastatin Pharmacokinetics

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A Bioequivalence Study of Empagliflozin/Metformin Fixed-Dose Combination in Healthy Subjects under Fasting Conditions

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Journal of Biosciences and Medicines 2024年第9期12卷 235-250页

作者： evelyn pena Alfredo Inatti Anyoly Taly José Chacón Xenon Serrano-Martin Department of Clinical Research Industrias Biocontrolled C.A. Grupo Leti S.A.V. Guarenas Venezuela Department of Research & Development Industrias Biocontrolled C.A. Grupo Leti S.A.V. Guarenas Venezuela Department of Medical Megat Laboratories Quito Ecuador

Background: This study evaluated the bioequivalence of empagliflozin 12.5 mg/metformin 1000 mg tablets compared to Synjardy® (Empagliflozin 12.5 mg/metformin 1000 mg) tablets in healthy male subjects under fasting conditions. Methods: This was a phase I, randomized, single-dose, two-period, two-sequence, crossover study to evaluate the bioequivalence (BE) profiles of two fixed-dose combinations (FDCs) of empagliflozin/metformin. Cmax, AUC0-t and AUC0-∞ from test and reference formulations were evaluated to access BE. The plasma concentrations were measured using a validated liquid chromatography-mass spectrometry (LC-MS/MS) method. Of the 24 subjects enrolled, 23 completed both periods of the study. The two formulations test and reference were considered bioequivalent if 90% confidence interval (CI) fell within 80.00% - 125.00% for Cmax, AUC0-t and AUC0-∞. Tolerability and safety were assessed throughout the study. Results: The pharmacokinetic (PK) parameters were similar between the test product (T) and reference product (R) Synjardy®. The 90% CI of the test/reference ratios of log-transformed PK parameters point estimates was Cmax: 89.87% (85.68% - 94.27%), AUC0-t: 87.91% (83.65% - 92.39%) and AUC0-∞: 87.16% (82.80% - 91.75%) to empagliflozin and Cmax: 92.19% (87.95% - 96.65%), AUC0-t: 91.38% (84.42% - 98.91%) and AUC0-∞: 93.78% (83.82% - 104.93%) to metformin respectively (90% CI for all PK parameters fell within 80.00% - 125.00%). Conclusion: Our results demonstrated BE between the test and reference formulations of oral tablets of empagliflozin 12.5 mg/metformin 1000 mg (FDC) in healthy male subjects under fasting conditions.

关键词： Bioequivalence Fix Dose Combinations Pharmacokinetic Empagliflozin

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Bioequivalence Study of Diclofenac 150 mg XR: A Single-Dose, Randomized, Open Label, 2-Period Crossover Study in Healthy Adult Volunteers

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Journal of Biosciences and Medicines 2023年第11期11卷 23-32页

作者： evelyn pena Alfredo Inatti Xenón Serrano Martin Department of Clinical Research Industrias Biocontrolled C.A. Caracas República Bolivariana de Venezuela

Objectives: Evaluate the bioequivalence (BE) of two oral tablets formulations of diclofenac 150 mg in healthy male subjects under fasting condition. This was a phase I, randomized, open label, balanced, two period, two sequences, single oral dose, crossover, analyst blind study. Methods: Twenty four (24) healthy subjects were randomly assigned to one of two sequences protocol: 150 mg XR of reference formulation (R), diclofenac sodium in the first period or the test formulation (T), diclofenac potassium in the second or vice versa. The plasma concentrations were determined using a validated LC-MS/MS method. Pharmacokinetic (PK) parameters included: maximum plasma concentration (Cmax), area under the plasma concentration—time curve from time 0 to the last measurable concentration (AUC0-t), and area under the plasma concentration—time from time 0 to infinity (AUC0-∞), were evaluated for BE. Results: The results showed that 90% confidence intervals for the test/reference geometric mean ratios (GMR) of Cmax (90.43 - 107.17), AUC0-t (93.08 - 116.46) and AUC0-∞ (92.52 - 117.39) were within the BE (80% - 125%) acceptance range. Conclusions: Two formulations, reference product (R) Voltaren® (diclofenac sodium) of Novartis and test product (T), Diklason Bi (diclofenac potassium) of Laboratorios Leti S.A.V., with a single dose of 150 mg XR, under fasting conditions were bioequivalent. No severe, serious or unexpected adverse events (AEs) were reported in this study.

关键词： Bioequivalence Diclofenac Pharmacokinetics

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The necessity to expand mycorrhizal boundaries:Including the fungal endophytes that possess key mycorrhizal criteria

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Pedosphere 2024年第2期34卷 520-523页

作者： Khalil KARIMAN Zed RENGEL Rodica pena Saleh RAHIMLOU Mark TIBBETT UWA School of Agriculture and Environment The University of Western AustraliaPerth WA 6009Australia Department of Sustainable Land Management&Soil Research Centre School of AgriculturePolicy and DevelopmentUniversity of ReadingReading RG66ARUK Department of Ecology and Evolutionary Biology University of MichiganAnn Arbor MI 48109USA

Dear editor,This letter aims to urge the necessity to expand the boundaries of mycorrhizal symbiosis to include certain root fungal *** conventional classification of mycorrhizal associations emphasizes specialized fu... 详细信息

关键词： editor specialized interface

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Everything is Primitive Accumulation?

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Fudan Journal of the Humanities and Social Sciences 2024年第2期17卷 337-360页

作者： David S.pena Joel Wendland-Liu Palm Beach State College Palm Beach GardensFLUSA Grand Valley State University AllendaleMIUSA

This paper explores the Marxist concept of primitive accumulation and its relationship to capitalist development. Primitive accumulation occurs as a historical process before the complete emergence of capitalism as the dominant mode of production. Primitive accumulation is distinguished from other forms of exploitation employed by capitalist societies to spread capitalism into non-capitalist regions. An exploration of different interpretations of primitive accumulation within Marxist theory highlights the transition from primary accumulation to capitalist accumulation in specific contexts. This paper provides a comprehensive overview of the multifaceted nature of primitive accumulation and its significance in the development of capitalism. It argues that many uses of primitive accumulation in the present context are erroneous.

关键词： Marxism Primitive accumulation Origins of capitalism Political economy

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Use of oilseed crops biomass for heavy metal treatment in water

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Oil Crop Science 2024年第3期9卷 177-186页

作者： Carlos pena-Guzman Angela Otalvaro-Alvarez Tatiana Jimenez-Ariza Environmental and Sanitation Engineering Program Faculty of EngineeringUniversidad de La SalleBogota111711Colombia Chemical Enineering Program Facultuy of EngineeringUniversidad de La SalleBogota111711Colombia Food Engineering Program Faculty of EngineeringUniversidad de La SalleBogota111711Colombia

The treatment of heavy metals in water is of high importance worldwide,and different treatment types have been *** use of plant material is becoming more and more important,and oilseed crops biomass have been investigated in terms of phytoremediation and biosorption *** article is a review of the literature reporting the applications in 10 different plants and evaluating the removal efficiencies for 12 metals,including the findings of 81 *** olifera and Helianthus annuus are the most studied plants,whereas Cu(21.9%),Cd(18.5%),and Pb(19.9%)are the most studied *** a result,it was found that more than 90%of Pb,Cu,Cd,Fe,Zn,Ni,Cr,Sr and Mn showed removals in their *** the same time,the variables most related to the efficiency of metal removal are pH,temperature,and contact *** article includes a review of the biosorption isotherms used in the different studies.

关键词： Oilseed crops Phytoremediation Biosorption Heavy metals

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Post-fire recovery of Puya raimondii, vegetation and birds in the puna of Huascarán National Park, Perú

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Journal of Mountain Science 2024年第1期21卷 20-32页

作者： Mery L.SUNI Giovana P.VADILLO César ARANA Enoc JARA-pena Letty SALINAS M.Estela PONCE Paul M.RAMSAY Plant Physiology Laboratory Faculty of Biological SciencesUniversidad Nacional Mayor de San MarcosLima 15081Peru Natural History Museum Universidad Nacional Mayor de San MarcosLima 15072Peru Applied Phytology Laboratory Faculty of Biological SciencesUniversidad Nacional Mayor de San MarcosLima 15081Peru Department of Statistics Faculty of Mathematical SciencesUniversidad Nacional Mayor de San MarcosLima 15081Peru Department of Chemical and Biological Sciences Universidad de las Américas PueblaSan Andrés Cholula CP Cholula CP 72810Mexico

A large fire of 233 ha in Huascarán National Park in Peru provided an opportunity to compare plant and bird responses in burned and nearby unburned zones of the puna. Heights and live diameters of flagship Puya raimondii rosettes(assigned to four broad developmental phases), plant communities(66 species in 24 families and nine growth forms) and bird communities(77 species in six trophic guilds) were monitored after the fire. Although no mortality was observed, Puya raimondii plants were affected by the fire, losing approximately 60% of their photosynthetic area across all developmental phases, but recovered quickly during the first two years after fire. The comparison of Puya rosette recovery after fire was complicated by the changes in live rosette diameter for unburned plants, which showed plasticity of photosynthetic area linked to seasonal and annual fluctuations in precipitation in this relatively dry environment(decreased by 26% for mature adult plants over the study period). Fire caused an immediate change in the density, biomass and composition of vegetation. Although the species present remained similar, their abundances changed significantly immediately after the fire, with notable reductions in dominant tussock grasses. This provided opportunities for other plants, resulting in higher postfire diversity of plant species, genera, families and growth forms. In turn, the changes in vegetation after fire affected the composition of birds according to their trophic guild. Granivores largely disappeared,generalists were mostly unaffected, and other guilds showed a more complex response. As the vegetation recovered, most displaced birds returned within approximately one year.

关键词： Burning Plant biomass Trophic guilds Andes Giant rosette plants

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Severe respiratory syncytial virus disease

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Journal of Intensive Medicine 2024年第4期4卷 405-416页

作者： Yolanda pena-López Joan Sabater-Riera Prithvi Raj Microbiome Research Laboratory(MRL) Department of ImmunologyUniversity of Texas Southwestern Medical CenterDallasTXUSA Pediatric Critical Care Department Hospital Universitari Vall d’HebronBarcelonaSpain Global Health eCore Vall d’Hebron Institute of ResearchBarcelonaSpain Intensive Care Department Servei de Medicina IntensivaIDIBELL-Hospital Universitari de BellvitgeL´Hospitalet de LlobregatBarcelonaSpain Bellvitge Biomedical Research Institute(IDIBELL) L’Hospitalet de LlobregatBarcelonaSpain

The burden of respiratory syncytial virus(RSV)disease is widely *** risk factors for severe disease,such as extreme ages,chronic cardiopulmonary conditions,and immunosuppression,typically coincide withpoorer *** the majority of RSV hospitalizations involve healthy children,a higher proportion ofhospitalized adults with underlying conditions need intensive ***,treatment primarily consists ofsupportive ***-induced wheezing should be distinguished from respiratory tract thickening,withoutresponse to *** RSV disease frequently overlaps with viral ***-invasivemechanical ventilation and high-flow oxygen therapy represented significant advancements in the managementof severe RSV disease in children and may also hold considerable importance in specific phenotypes of RSV diseasein *** severe infections manifest with refractory hypoxemia necessitating more advanced ventilatorysupport and/or extracorporeal membrane oxygenation *** bacterial co-infection rates are low,they have been associated with worse *** prescription rates are *** diagnosingbacterial co-infections remains a *** evidence and antibiotic stewardship policies advise againstindiscriminate antibiotic usage,even in severe *** role of currently developing antiviral therapies in severeRSV disease will be elucidated in the coming years,contingent upon the success of new vaccines and immunepassive strategies involving nirsevimab.

关键词： RSV Bronchiolitis Co-infection Pneumonia ARDS Respiratory failure

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Step‑by‑Step Modulation of Crystalline Features and Exciton Kinetics for 19.2%Efficiency Ortho‑Xylene Processed Organic Solar Cells

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Nano-Micro Letters 2024年第2期16卷 258-272页

作者： Bosen Zou Weiwei Wu Top Archie Dela pena Ruijie Ma Yongmin Luo Yulong Hai Xiyun Xie Mingjie Li Zhenghui Luo Jiaying Wu Chuluo Yang Gang Li He Yan Department of Chemistry Department of Chemistry and Hong Kong Branch of Chinese National Engineering Research Center for Tissue Restoration and Reconstruction The Hong Kong University of Science and TechnologyClear Water BayHong KongPeople’s Republic of China Department of Electronic and Information Engineering Research Institute for Smart Energy(RISE)Guangdong‑Hong Kong‑Macao(GHM)Joint Laboratory for Photonic‑Thermal‑Electrical Energy Materials and DevicesThe Hong Kong Polytechnic UniversityHung HomKowloonHong Kong 999077People’s Republic of China The Hong Kong University of Science and Technology Function HubAdvanced Materials ThrustNanshaGuangzhou 511400People’s Republic of China Department of Applied Physics The Hong Kong Polytechnic UniversityHong KongPeople’s Republic of China Shenzhen Key Laboratory of New Information Display and Storage Materials College of Materials Science and EngineeringShenzhen UniversityShenzhen 518060People’s Republic of China

With plenty of popular and effective ternary organic solar cells(OSCs)construction strategies proposed and applied,its power conversion efficiencies(PCEs)have come to a new level of over 19%in single-junction ***,previous studies are heavily based in chloroform(CF)leaving behind substantial knowledge deficiencies in understanding the influence of solvent choice when introducing a third ***,we present a case where a newly designed asymmetric small molecular acceptor using fluoro-methoxylated end-group modification strategy,named BTP-BO-3FO with enlarged bandgap,brings different morphological evolution and performance improvement effect on host system PM6:BTP-eC9,processed by CF and ortho-xylene(o-XY).With detailed analyses supported by a series of experiments,the best PCE of 19.24%for green solvent-processed OSCs is found to be a fruit of finely tuned crystalline ordering and general aggregation motif,which furthermore nourishes a favorable charge generation and recombination ***,over 19%PCE can be achieved by replacing spin-coating with blade coating for active layer *** work focuses on understanding the commonly met yet frequently ignored issues when building ternary blends to demonstrate cutting-edge device performance,hence,will be instructive to other ternary OSC works in the future.

关键词： Organic solar cells Ternary design Solvent selection Flouro-methoxylated end group Morphological ordering

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Synthesis of coral-like structures of Pr-Yb co-doped YIG: Structural,optical, magnetic and antimicrobial properties

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Journal of Rare Earths 2024年第3期42卷 543-554,I0004页

作者： A.Fernandez Francisca P.Araujo Y.Guerra S.Castro-Lopes J.Matilla-Arias Idglan S.de Lima Edson C.Silva-Filho Josy A.Osajima F.Guerrero R.pena-Garcia Federal University of Piau Graduate Program in Materials Science and EngineeringTeresinaPIBrazil Federal Rural University of Pernambuco Academic Unit of Cabo de Santo AgostinhoCabo de Santo AgostinhoPEBrazil Federal University of Piaui Department of PhysicTeresinaPBrazil Federal University of Pernambuco Graduate Program in Materials ScienceRecifePEBrazil University of Granma Departmentof Basic Sciences and Applied InformaticsFaculty of Technical SciencesBayamoCuba Federal University of Amazonas Department of PhysicManausAMBrazil Federal University of Pernambuco Department of PhysicRecifePEBrazil

Coral-like structures of the Y_(3-x)Pr_(x)Fe_(5-y)Yb_(y)O_(12),(0.00 ≤ x ≤ 0.04, 0.00 ≤ y ≤ 0.02) compound were synthesized using the sol-gel method. Structural investigation certified the YIG cubic crystal structure formation, without any secondary phase. It is shown that, the relatively large ionic radius of the dopant cations results in an expansion of the lattice parameter, variations in the Iona-O-Iondangle, Iona-O,Iond-O and Ionc-O bond distances and decrease in the average crystallite size. Fourier transform infrared(FTIR) and Raman measurements are essential to testify the single-phase formation of YIG crystal structure and are observed changes in the stretching and vibrational modes, respectively. The morphological study, energy dispersive spectroscopy(EDS) spectra and textural properties show corallike structures, peaks associated with Pr^(3+) and Yb^(3+) atoms and the effect of dopants on surface area,diameter, and pore volume, respectively. The optical analysis from diffuse reflectance spectra witnessed an increase in the optical gap band, a decrease in Urbach energy and blue shift in the charge transfer,correlated with the expansion of the unit cell due to the dopant's insertion in the YIG structure. A typical ferrimagnetic behavior is exhibited by the Y_(3-x)Pr_(x)Fe_(5-y)Yb_(y)O_(12)compound. The saturation magnetization(M_(s)), cubic anisotropy constant(K_(1)) and coercive field(H_(c)) increase with the Pr^(3+)cations content, as consequence of their magnetic nature and distribution around of Fe^(3+)ions due to the coexistence with the Yb^(3+). Finally, for the first time, antibacterial tests by mean of the direct contact method were performed for YIG co-doped with Pr^(3+)and Yb^(3+)and it is shown that, relatively high dosages of Pr^(3+) cations favored the activity against S. aureus, therefore, a new biological property for YIG doped with rare earths is presented.

关键词： Yttrium iron garnet(YIG) Coral-like structures Rare earths Band gap energy Magnetic properties Antimicrobial properties

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