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The Role of ADME in Drug Safety Evaluation

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The Role of ADME in Drug Safety Evaluation

药物非临床安全性研究学术研讨会

作者： Michelle M He lisa A.Shipley carl l.mcmillian Ph.D.Research Advisor Drug Disposition Lilly Research LaboratorieDivision of Eli Lilly and Comp Ph.D.Vice President Drug Disposition Lilly Research LaboratorieDivision of Eli Lilly and Comp Ph.D.Director Pathology and Investigative Toxicology Lilly Research LaboratorieDivision of Eli Lilly and Comp

Role of ADME in Safety Assessment ·Delineates the Absorption,Distribution, Metabolism and Excretion of drug candidates in animals and humans ·Determines exposure in Toxicology Studies to establish Margins of Safety

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毒理学与发现药物的相互关系

毒理学与发现药物的相互关系

药物非临床安全性研究学术研讨会

作者： carl l.mcmillian 礼来公司礼来研究实验室

毒理学参与从研发到投放市场的连续过程…目标是首次人的给药剂量(FHD)

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ADME在药品毒理学评价中的作用

ADME在药品毒理学评价中的作用

药物非临床安全性研究学术研讨会

作者： Michelle M．He lisa A．Shipley carl l.mcmillian 礼来公司礼来研究实验室礼来公司礼来研究实验室礼来公司礼来研究实验室病理及毒理学研究室

ADME 在安全性评价中的作用·描述候选药物在动物和人体内的吸收、分布、代谢和扫泄(ADME) ·在毒理学研究中测定暴露量以确定安全范围(MOS)

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NUMERICAl SIMUlATION OF THE XZ TAURI SUPERSONIC ASTROPHYSICAl JET

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Acta Mathematica Scientia 2009年第6期29卷 1677-1683页

作者： carl l. Gardner Steven J. Dwyer School of Mathematical and Statistical Sciences Arizona State University Tempe AZ 85287 USA

Computational gas dynamical simulations using the WENO-lF method are applied to modeling the high Mach number astrophysical jet XZ Tauri, including the effects of radiative cooling. Mach 55 simulations of the pulsed proto-jet are presented and analyzed in terms of interacting nonlinear waves： terminal Mach disks, bow shocks, and Meshkov-Richtmyer instabilities of the leading jet contact boundary.

关键词： astrophysical jets ENO. method gas dynamics

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Prenatal multiple micronutrient-fortified balanced energy-protein supplementation and newborn telomere length and mitochondrial DNA content: a randomized controlled efficacy trial in rural Burkina Faso

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Food Science and Human Wellness 2024年

作者： Giles T.Hanley-Cook Yuri Bastos-Moreira Dries S.Martens Trenton Dailey-Chwalibóg laeticia Celine Toe Brenda de Kok lionel Ouédraogo Alemayehu Argaw Kokeb Tesfamariam Patrick Kolsteren lieven Huybregts Tim S.Nawrot Sarah De Saeger Marthe De Boevre carl lachat Department of Food Technology， Safety and Health， Faculty of Bioscience Engineering， Ghent University Center of Excellence in Mycotoxicology and Public Health， MYTOXSOUTH~(?) Coordination Unit， Faculty of Pharmaceutical Sciences， Ghent University Centre for Environmental Sciences， Hasselt University Unité Nutrition et Maladies Métaboliques， Institut de Recherche en Sciences de la Santé (IRSS) Centre Muraz Center of Excellence in Mycotoxicology and Public Health， MYTOXSOUTH? Coordination Unit， Faculty of Pharmaceutical Sciences， Ghent University Nutrition， Diets， and Health Unit， Department of Food and Nutrition Policy， International Food Policy Research Institute (IFPRI) Department of Public Health & Primary Care， University of leuven Department of Biotechnology and Food Technology， Faculty of Science， University of Johannesburg， Doornfontein Campus

Background: Evidence regarding the effectiveness of prenatal nutritional supplements has mainly considered anthropometric pregnancy outcomes. The effect on markers of health and disease， such as offspring telomere length (Tl) and mitochondrial DNA content (mtDNAc) is unknown. Objectives: We assessed the efficacy of maternal multiple micronutrient (MMN)-fortified balanced-energy protein (BEP) and iron-folic acid (IFA) supplementation on newborn Tl as a secondary outcome and mtDNAc as a non-declared outcome. Design: We conducted a randomized controlled trial in rural Burkina Faso， among pregnant females (15-40 years old) enrolled at ly (control) throughout pregnancy. Whole arterial blood samples were collected from the umbilical cord of 104 control and 90 intervention group infants， respectively. Average relative Tl and mtDNAc were measured using quantitative polymerase chain reaction. linear regression models were fitted to assess Tl and mtDNAc differences across trial arms. Results: We found that a combined daily MMN-fortified BEP supplement and IFA tablet did not affect newborn Tl [β = -0.010 (95% CI: -0.057， 0.036); P = 0.662] or mtDNAc [β = 0.065 (95% CI: -0.203， 0.073); P = 0.354]， as compared to an IFA tablet alone. These findings were confirmed (P > 0.05) by adjusting the regression models for potential prognostic factors of study outcomes at enrollment. Exploratory analyses indicated higher， but non-significantly different mtDNAc among children born either small-for-gestational age， low birthweight， or preterm. Conclusions: Newborns from mothers who received daily nutritional supplements across gestation did not have different relative Tl or mtDNAc.

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Effect of tetrandrine on cellular electrophysiology and calcium uptake of myocardium in guinea pigs and dogs

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Chinese Medical Journal 2001年第10期114卷 38-42,105页

作者：管思明 carl lynch Ⅲ 华中科技大学同济医学院附属协和医院老年医学科武汉430022 佛吉尼亚大学

Objective To study the effects of tetrandrine, a Chinese herbal medicine, on the action potential (AP),contraction as well as sarcoplasmic reticulum (SR) calcium uptake of myocardium in guinea-pigs and *** Changes in AP, dV/dt, peak tension (PT) and dT/dt of myocardial cells were studied using the technique of glass electrode. Changes of the calcium uptake rate by sarcoplasmic reticulum and release of inorganic phosphate from sarcoplasmic reticulum were assessed with biochemical *** Tetrandrine exerts a concentration-dependent and frequency-dependent negative inotropic effect and shortens action potential duration. Tetrandrine depresses both dT(E)/dt and dT(l)/dt as well as the tension of myocardium, and reduces dV/dt and amplitude only in the slow action potential, thus implying that tetrandrine blocks the slow calcium channel. In addition, compared with thapsigargin, a specific inhibitor of Ca2+-ATPase on SR, tetrandrine more apparently suppresses the contraction of the *** Tetrandrine is a wide-range calcium antagonist of plant origin. Not only it blocks the voltageoperated calcium channels as other authors reported, but also may play an important role in affecting the function of Ca2+ -ATPase and calcium release channels on SR. From this study, we also suggest that the calcium channel appears to be more critical than SR for the contraction of my ocardium.

关键词： tetrandrine · electrophysiology · myocardium · Ca 2+ ATPase · cardiac sarcoplasmic reticulum

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A Hunter-Gatherer Exercise Prescription to Optimize Health and Well-Being in the Modern World

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Journal of Science in Sport and Exercise 2021年第2期3卷 147-157页

作者： Evan l.O’Keefe carl J.lavie Ochsner Clinical School The University of Queensland School of MedicineNew OrleansLAUSA Department of Cardiovascular Diseases John Ochsner Heart and Vascular Institute1514 Jefferson HighwayNew OrleansLA 70121-2483USA

There has been considerable innovation and advancement in the field of exercise and physical activity (PA).In regards to the battle against chronic non-communicable disease,however,we believe the model of PA that would prove most salu-tary is one closely mimicking that of our hunter-gatherer *** the purpose of longevity,the human body and our genetic makeup have been evolutionarily adapted to respond best to moderate amounts of high-intensity interval training,in conjunction with high amounts of low intensity ***,to optimize resiliency and cardiorespiratory fitness,a hunter-gatherer fitness regimen must include cross training targeted at flexibility,balance and *** not com-monly understood,the health benefits from exercise comprise a reverse *** endurance athletes residing on the furthest reaches of the PA spectrum appear to lose a substantial portion of the exercise-related longevity and cardiovascular benefits due to cardiac overuse ***,there is an emerging body of evidence suggesting leisure time exercise done with peers in a natural environment is significantly superior to that training done in *** idea of the "power of play" lends support to the ancestral model of PA whereby humans are evolutionary adapted to be highly social,outdoor creatures capable of a diverse range of PA at varying intensities.

关键词： Hunter-gatherer Cardiovascular disease Physical activity Exercise

Field report:Exploring the Doonerak fenster of the central Brooks Range,Alaska,USA

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Geoscience Frontiers 2017年第4期8卷 915-918页

作者： Justin V.Strauss carl W.Hoiland lyle l.Nelson Department of Earth Sciences Dartmouth College Department of Geological Sciences Stanford University Department of Earth and Planetary Sciences Harvard University

Arctic Alaska is a ＇suspect＇ terrane that encompasses approximately 20%of Alaska,stretching from the southern Brooks Range all the way to the continental shelves of the Chukchi and Beaufort *** the origin and subsequent travels of this large crustal fragment are debated among geologists,most researchers agree upon its composite nature and exotic *** constrain the early geological history of this terrane,we describe a recent expedition to the Doonerak fenster of the central Brooks *** area has long been regarded as a key locality for understanding the structural evolution of the Mesozoic-Cenozoic Brooks Range orogen;however,our target was different：a unique sequence of volcanic and siliciclastic rocks（Apoon assemblage） exposed beneath a profound pre-Mississippian unconformity,which we argue is of key importance to understanding the early Paleozoic tectonic history of northern Alaska and the greater Arctic.

关键词： Arctic Alaska Doonerak fenster Brooks Range Apoon assemblage

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Homicidal Abuse of Young Children:A Historical Perspective

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Journal of Forensic Science and Medicine 2017年第2期3卷 97-110页

作者： Rudy J Castellani Joyce l deJong carl J Schmidt Department of Pathology Western Michigan University Homer Stryker M.D.School of MedicineKalamazoo Department of Pathology Wayne County Medical ExaminerUniversity of MichiganDetroitMlUSA

The past 50 years has seen a heightened awareness of abusive injury patterns and increased concern for the plight of children victimized by their *** of the young,however,has been embedded in society since the beginning of recorded ***,nature provides abundant examples of infanticide in lower animals,raising the question of whether exploitation,apathy,and violence toward children are on some level evolutionarily *** human antiquity,selective killing of females,the illegitimate,and the malformed,killing by ritualistic sacrifice or to conserve resources was carried out with *** middle ages and later saw a decline in these practices albeit *** hundred years into the industrial revolution,with harsh child labor in public view,legal remedies were sought to protect children but with little *** domestic abuse of children was not addressed until a pivotal 19^(th)-century case,in which the rights of animals were invoked to intervene on behalf of a *** the 20th century,physicians began to look closely at anatomical findings;patterns due to trauma,especially inflicted trauma,began to emerge.“Battered child syndrome”was followed by“shaken baby syndrome”,the latter prompted by the recurrent findings of subdural hematoma,retinal hemorrhages,and brain injury with the absence of impact injuries and no plausible accidental or natural disease *** the 21st century,high-quality studies and an emphasis on evidenced-based medicine substantiated the existence ofiiijury patterns resulting from homicidal ***,progress has been uneven.A case of child abuse that reached the US Supreme Court resulted in an ill-cited dissent that seems to have amplified an already toxic medicolegal environment,perhaps *** difficulties in balancing the welfare of society with that of caregivers in the aftermath of homicidal abuse will no doubt continue.

关键词： Abusive head trauma child abuse homicide infanticide