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PERFORMANCE ANALYSIS OF THE SEGMENT ALIGNMENT CONTROL-SYSTEM FOR THE 10-METER TELESCOPE

AUTOMATICA 1988年第4期24卷 437-453页

作者： AUBRUN, JN LORELL, KR HAVAS, TW HENNINGER, WC APPL COMP RESOURCES INC SANTA CRUZCA 95061

The W. M. Keck Observatory Ten-Meter Telescope (TMT) will be a high-performance astronomical telescope capable of unprecedented ground-based observations. One of the unique features of the TMT is its primary mirror which is composed of 36 hexagonal segments. A segment alignment control system will be used to achieve the optical quality of a glass monolith in the segmented primary mirror. The problems associated with the accurate pointing and imaging of a large flexible telescope such as the TMT are quite different from those posed by traditional rigid telescopes. These problems arise from two main sources: structural dynamic effects, such as enhanced sensitivity to external disturbances, and interactions between the segment alignment control system and the telescope structure. This study consists of a combined structural and control system analysis based upon mathematical models of the TMT structure, the segment alignment control system, and the aerodynamic loads on the primary mirror that are induced by the wind. Data for the structural model were derived from the most recent design iteration available during the time frame of the study. Actual wind velocities measured at three observatory sites were used to develop a generic model of the power spectrum of forces generated by wind loads. Information about the r.m.s. mirror figure errors and limits on the bandwidth of the control system as it is currently implemented are presented.

关键词： Control theory dynamic response dynamic stability finite-element method large-scale systems model reduction modeling multivariable control system optical variables control system analysis vibration control

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Representing Micro-Business Requirements Patterns with Associated Software components

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INTERNATIONAL JOURNAL OF INFORMATION SYSTEM MODELING AND DESIGN 2014年第4期5卷 71-90页

作者： Macasaet, R. J. Noguera, Manuel Luisa Rodriguez, Maria Luis Garrido, Jose Supakkul, Sam Chung, Lawrence Pentathlon Syst Resources Inc Dept Software Res & Dev Res & Dev Efforts Manila Philippines Univ Granada Dept Comp Languages & Syst Granada Spain Sabre Inc Travel Tchnol Co Appl Architecture Sabre Travel Network Southlake TX USA Univ Texas Dallas Dept Comp Sci Richardson TX USA

This paper proposes representations for micro-business requirements patterns with associated software components. The patterns must be comprehensible enough for micro-business owners without technical backgrounds but at the same time be technical enough for the software developers who use them during the design and development of software. Both objectives are somewhat conflicting and trade-offs have to be made regarding their representations. The pattern representations use a combination of tables, business process models, goal graphs, labels, and UML component diagrams. First, the paper provides an example of a micro-business requirements pattern in the form of an inventory pattern and applies it in a real-world micro-business case, a clothes retail store. Through the example, it shows how the pattern is instantiated and associated with software components. Then, it shows how the patterns are applied in industrial practice, including the software development companies currently adapting and applying them, accompanied by observable strengths and weaknesses.

关键词： Business Process Modeling component-Based Development Functional Requirements Micro-Business Non-Functional Requirements Requirements Pattern Reusable Software Softgoal Interdependency Graphs Software components UML

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Next generation Arctic vegetation maps: Aboveground plant biomass and woody dominance mapped at 30 m resolution across the tundra biome

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REMOTE SENSING OF ENVIRONMENT 2025年 323卷

作者： Orndahl, Kathleen M. Berner, Logan T. Macander, Matthew J. Arndal, Marie F. Alexander, Heather D. Humphreys, Elyn R. Loranty, Michael M. Ludwig, Sarah M. Nyman, Johanna Juutinen, Sari Aurela, Mika Mikola, Juha Mack, Michelle C. Rose, Melissa Vankoughnett, Mathew R. Iversen, Colleen M. Kumar, Jitendra Salmon, Verity G. Yang, Dedi Grogan, Paul Danby, Ryan K. Scott, Neal A. Olofsson, Johan Siewert, Matthias B. Deschamps, Lucas Maire, Vincent Levesque, Esther Gauthier, Gilles Boudreau, Stephane Gaspard, Anna Bret-Harte, M. Syndonia Raynolds, Martha K. Walker, Donald A. Michelsen, Anders Kumpula, Timo Villoslad, Miguel Ylanne, Henni Luoto, Miska Virtanen, Tarmo Greaves, Heather E. Forbes, Bruce C. Heim, Ramona J. Hoelzel, Norbert Epstein, Howard Bunn, Andrew G. Holmes, Robert Max Natali, Susan M. Virkkala, Anna-Maria Goetz, Scott J. No Arizona Univ Sch Informat Comp & Cyber Syst 1295 Knoles Dr Flagstaff AZ 86011 USA ABR Inc Environm Res & Serv Fairbanks AK USA Aarhus Univ Dept Ecosci Aarhus Denmark Auburn Univ Coll Forestry Wildlife & Environm Auburn AL USA Carleton Univ Dept Geog & Environm Studies Ottawa ON Canada Colgate Univ Dept Geog Hamilton NY USA Columbia Univ Dept Earth & Environm Sci Palisades NY USA Cornell Univ Jeb E Brooks Sch Publ Policy Ithaca NY USA Finnish Meteorol Inst Helsinki Finland Nat Resources Inst Finland Bioecon & Environm Unit Helsinki Finland No Arizona Univ Ctr Ecosyst Sci & Soc Flagstaff AZ USA No Arizona Univ Dept Biol Sci Flagstaff AZ USA Nova Scotia Community Coll Appl Res Middleton NS Canada Oak Ridge Natl Lab Climate Change Sci Inst Oak Ridge TN USA Oak Ridge Natl Lab Environm Sci Div Oak Ridge TN USA Oak Ridge Natl Lab Environm Sci Div Oak Ridge TN USA Queens Univ Dept Biol Kingston ON Canada Queens Univ Dept Geog & Planning Kingston ON Canada Umea Univ Dept Ecol & Environm Sci Umea Sweden Univ Quebec Trois Rivieres Dept Sci Environm Trois Rivieres PQ Canada Univ Quebec Trois Rivieres Dept Sci Environm Trois Rivieres PQ Canada Univ Quebec Trois Rivieres Ctr Etud Nord Trois Rivieres PQ Canada Univ Laval Ctr Etud Nord Quebec City PQ Canada Univ Laval Dept Biol Quebec City PQ Canada Univ Alaska Fairbanks Inst Arctic Biol Fairbanks AK USA Univ Copenhagen Dept Biol Copenhagen Denmark Univ Eastern Finland Dept Geog & Hist Studies Joensuu Finland Univ Eastern Finland Sch Forest Sci Joensuu Finland Univ Helsinki Dept Geosci & Geog Helsinki Finland Univ Helsinki Ecosyst & Environm Res Programme Helsinki Finland Univ Idaho Dept Nat Resources & Soc Moscow ID USA Univ Lapland Arctic Ctr Rovaniemi Finland Univ Munster Inst Landscape Ecol Munster Germany Univ Virginia Dept Environm Sci Charlottesville VA USA Western Washington Univ Dept Environm Sci Bellingham WA USA Woodwell Climate Res Ctr Falmouth MA US

The Arctic is warming faster than anywhere else on Earth, placing tundra ecosystems at the forefront of global climate change. Plant biomass is a fundamental ecosystem attribute that is sensitive to changes in climate, closely tied to ecological function, and crucial for constraining ecosystem carbon dynamics. However, the amount, functional composition, and distribution of plant biomass are only coarsely quantified across the Arctic. Therefore, we developed the first moderate resolution (30 m) maps of live aboveground plant biomass (g m(-2)) and woody plant dominance (%) for the Arctic tundra biome, including the mountainous Oro Arctic. We modeled biomass for the year 2020 using a new synthesis dataset of field biomass harvest measurements, Landsat satellite seasonal synthetic composites, ancillary geospatial data, and machine learning models. Additionally, we quantified pixel-wise uncertainty in biomass predictions using Monte Carlo simulations and validated the models using a robust, spatially blocked and nested cross-validation procedure. Observed plant and woody plant biomass values ranged from 0 to similar to 6000 g m(-2) (mean approximate to 350 g m(-2)), while predicted values ranged from 0 to similar to 4000 g m(-2) (mean approximate to 275 g m(-2)), resulting in model validation root-mean-squared-error (RMSE) approximate to 400 g m(-2) and R-2 approximate to 0.6. Our maps not only capture large-scale patterns of plant biomass and woody plant dominance across the Arctic that are linked to climatic variation (e.g., thawing degree days), but also illustrate how fine-scale patterns are shaped by local surface hydrology, topography, and past disturbance. By providing data on plant biomass across Arctic tundra ecosystems at the highest resolution to date, our maps can significantly advance research and inform decision-making on topics ranging from Arctic vegetation monitoring and wildlife conservation to carbon accounting and land surface modeling.

关键词： Pan Arctic Plant biomass Woody plant dominance Vegetation distribution Remote sensing Climate change Landsat

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Prevalence of antibiotic-resistant E. coli in broilers challenged with a multi-resistant E. coli strain and received ampicillin, an organic acid-based feed additive or a synbiotic preparation

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POULTRY SCIENCE 2019年第6期98卷 2598-2607页

作者： Roth, Nataliya Hofacre, Charles Zitz, Ulrike Mathis, Greg F. Moder, Karl Doupovec, Barbara Berghouse, Roy Domig, Konrad J. BOKU Univ Nat Resources & Life Sci Inst Food Sci Dept Food Sci & Technol A-1190 Vienna Austria Univ Georgia Poultry Diagnost & Res Ctr Dept Populat Hlth Athens GA 30602 USA BOKU Univ Nat Resources & Life Sci Inst Appl Stat & Comp A-1190 Vienna Austria BIOMIN Holding GmbH A-3131 Getzersdorf Austria Southern Poultry Res Grp Inc Athens GA 30607 USA

The aim of this study was to evaluate the effect of ampicillin, an organic acid-based feed additive and a synbiotic preparation on the prevalence of antibiotic-resistant E. coli in the ceca of broilers. A total of 2000 broiler chickens (Ross 708) were randomly assigned to 5 groups with 8 replicates. The negative control group was the only group that was not subjected to avian pathogenic E. coli challenge, while all the other 4 groups received a multi-resistant E. coli strain that was resistant to ampicillin, cephalexin, and nalidixic acid as an oral challenge. The second group served as a challenge control, and the third group received the antibiotic ampicillin via water for 5 d. The fourth group received a feed additive based on organic acids and cinnamaldehyde, and the fifth group received a synbiotic preparation via feed and water. On day 17 and 38 of the trial, cecal samples from 3 birds from each of the 40 pens were obtained, and the E. coli counts and abundances of antibiotic-resistant E. coli were determined. Oral challenge with an avian pathogenic E. coli strain did not influence the performance, and there was no significant difference in growth performance between groups. The total E. coli count was lower (P < 0.05) in the group supplemented with the synbiotic than in the challenge control group on day 38 of the trial. Administration of an antibiotic for 5 d led to a significant increase in the abundance of E. coli strains resistant to ampicillin, amoxicillin-clavulanic acid, cefoxitin, and ceftriaxone. There was no increase in the abundance of antibiotic-resistant E. coli observed in the groups that received feed supplemented with an organic acid/cinnamaldehyde-based feed additive or a synbiotic. Moreover, the effects of the tested feed additives on the prevalence of resistant E. coli are demonstrated by the lower ceftriaxone minimal inhibitory concentration values for this group than for the antibiotic group. Additionally, the synbiotic group exhibited lo

关键词： feed additive poultry antibiotic resistance APEC E. coli challenge

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Scalable process for application of stabilized lithium metal powder in Li-ion batteries

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JOURNAL OF POWER SOURCES 2016年 309卷 33-41页

作者： Ai, Guo Wang, Zhihui Zhao, Hui Mao, Wenfeng Fu, Yanbao Yi, Ran Gao, Yue Battaglia, Vincent Wang, Donghai Lopatin, Sergey Liu, Gao Univ Calif Berkeley Lawrence Berkeley Natl Lab Energy Storage & Distributed Resources Div Energy Technol Area Berkeley CA 94720 USA Minist Ind & Informat Technol Sci & Technol Reliabil Phys & Applicat Elect Comp Elect Res Inst 5 Guangzhou 510610 Guangdong Peoples R China Penn State Univ Dept Mech & Nucl Engn University Pk PA 16802 USA Appl Mat Inc Santa Clara CA 95054 USA

A simple solution processing method is developed to achieve a uniform and scalable stabilized lithium metal powder (SLMP) coating on a Li-ion negative electrode. A solvent and binder system for the SLMP coating is developed, including the selection of solvent, polymer binder, and optimization of polymer concentration. The optimized binder solution is a 1% concentration of polymer binder in xylene;a mixture of polystyrene-co-butadiene) rubber (SBR) and polystyrene (PS) is chosen as the polymer binder. Results show that long-sustained, uniformly dispersed SLMP suspension can be achieved with the optimized binder solution. The uniform SLMP coating can be achieved using a simple "doctor blade" coating method, and the resulting SLMP coating can be firmly glued on the anode surface. By using SLMP to prelithiate the negative electrode, improvements in electrochemical performances are demonstrated in both graphite/NMC and SiO/NMC full cells. (C) Published by Elsevier B.V.

关键词： Stabilized lithium metal powder (SLMP (R)) Prelithiation SiO Full cell

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Does a detailed model of the electricity grid matter? Estimating the impacts of the Regional Greenhouse Gas Initiative

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RESOURCE AND ENERGY ECONOMICS 2014年第1期36卷 191-207页

作者： Shawhan, Daniel L. Taber, John T. Shi, Di Zimmerman, Ray D. Yan, Jubo Marquet, Charles M. Qi, Yingying Mao, Biao Schuler, Richard E. Schulze, William D. Tylavsky, Daniel Rensselaer Polytech Inst Sage Lab Dept Econ Troy NY 12180 USA Resources Future Inc Washington DC 20036 USA Cornell Univ Dyson Sch Appl Econ & Management Ithaca NY 14853 USA Arizona State Univ Sch Elect Comp & Energy Engn Tempe AZ 85287 USA Cornell Univ Dept Operat Res & Ind Engn Ithaca NY 14853 USA Cornell Univ Dept Civil & Environm Engn Ithaca NY 14853 USA

The consequences of environmental and energy policies in the U.S. can be severely constrained by physical limits of the electric power grid. Flows do not follow the shortest path but are distributed over all lines in accordance with the laws of physics, so grid operators must select which generation units to operate at each moment, not only to minimize production costs, but also to prevent the system from collapsing because of line overloads. Because of the complexity of power grid operation, computing limitations have until very recently made it impossible to solve a policy analysis or planning model that combines realistic modeling of flows with a detailed transmission system model and the prediction of generator investment and retirement. We construct and solve a model of the eastern US and Canada that combines these characteristics. Then, because a smaller model would be usable for some additional purposes, we explore the effects of transmission model simplification on the accuracy of simulation results. To evaluate the amount of detail necessary, we simulate the short- and long-term effects of imposing a price on the carbon dioxide emissions from the power plants in nine northeastern US states, as the Regional Greenhouse Gas Initiative does. We consider three grid models that simplify the actual 62,000-node system to varying degrees. Our 5000-node model matches the 62,000-node model very closely. We use it as the basis for evaluating the more simplified models: a 300-node model and a model with just one node, i.e. no transmission constraints. With each of the three models, we predict the carbon dioxide emission impacts, electricity price impacts, and generator entry and exit impacts of the emission price, over the next 20 years. We find that most of the impact predictions produced by the 300- and one-node models differ from those of the 5000-node model by more than 20%, and some by much more. Fortunately, the 5000-node model, and others with its combination of

关键词： Electricity market Simulation modeling Cost-benefit analysis Long term Carbon dioxide

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Genome resources for climate-resilient cowpea, an essential crop for food security

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PLANT JOURNAL 2017年第5期89卷 1042-1054页

作者： Munoz-Amatriain, Maria Mirebrahim, Hamid Xu, Pei Wanamaker, Steve I. Luo, MingCheng Alhakami, Hind Alpert, Matthew Atokple, Ibrahim Batieno, Benoit J. Boukar, Ousmane Bozdag, Serdar Cisse, Ndiaga Drabo, Issa Ehlers, Jeffrey D. Farmer, Andrew Fatokun, Christian Gu, Yong Q. Guo, Yi-Ning Huynh, Bao-Lam Jackson, Scott A. Kusi, Francis Lawley, Cynthia T. Lucas, Mitchell R. Ma, Yaqin Timko, Michael P. Wu, Jiajie You, Frank Barkley, Noelle A. Roberts, Philip A. Lonardi, Stefano Close, Timothy J. Univ Calif Riverside Dept Bot & Plant Sci Riverside CA USA Univ Calif Riverside Dept Comp Sci & Engn Riverside CA USA ZAAS Inst Vegetables Hangzhou 310021 Peoples R China Univ Calif Davis Dept Plant Sci Davis CA USA Savanna Agr Res Inst Council Sci & Ind Res Tamale Ghana Inst Environm & Rech Agr Saria Burkina Faso Int Inst Trop Agr Kano Nigeria Marquette Univ Dept Math Stat & Comp Sci Milwaukee WI USA Inst Senegalais Rech Agr Thies Senegal Bill Melinda Gates Fdn Seattle WA USA Natl Ctr Genome Resources Santa Fe NM USA Int Inst Trop Agr Ibadan Nigeria USDA ARS Western Reg Res Ctr Albany CA USA Univ Calif Riverside Dept Nematol Riverside CA USA Univ Georgia Ctr Appl Genet Technol Athens GA USA Illumina Inc San Francisco CA USA Univ Virginia Dept Biol Charlottesville VA USA Agr & Agri Food Canada Morden MB Canada USDA ARS Plant Genet Resources Conservat Unit Griffin GA USA

Cowpea (Vigna unguiculata L. Walp.) is a legume crop that is resilient to hot and drought-prone climates, and a primary source of protein in sub-Saharan Africa and other parts of the developing world. However, genome resources for cowpea have lagged behind most other major crops. Here we describe foundational genome resources and their application to the analysis of germplasm currently in use in West African breeding programs. resources developed from the African cultivar IT97K-499-35 include a whole-genome shotgun (WGS) assembly, a bacterial artificial chromosome (BAC) physical map, and assembled sequences from 4355 BACs. These resources and WGS sequences of an additional 36 diverse cowpea accessions supported the development of a genotyping assay for 51 128 SNPs, which was then applied to five bi-parental RIL populations to produce a consensus genetic map containing 37 372 SNPs. This genetic map enabled the anchoring of 100 Mb of WGS and 420 Mb of BAC sequences, an exploration of genetic diversity along each linkage group, and clarification of macrosynteny between cowpea and common bean. The SNP assay enabled a diversity analysis of materials from West African breeding programs. Two major subpopulations exist within those materials, one of which has significant parentage from South and East Africa and more diversity. There are genomic regions of high differentiation between subpopulations, one of which coincides with a cluster of nodulin genes. The new resources and knowledge help to define goals and accelerate the breeding of improved varieties to address food security issues related to limited-input small-holder farming and climate stress.

关键词： BAC sequencing consensus genetic map cowpea genetic anchoring iSelect genotyping array Phaseolus vulgaris L. synteny Vigna unguiculata L. Walp. West Africa WGS sequencing

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Geomagnetically induced currents: Science, engineering, and applications readiness

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SPACE WEATHER-THE INTERNATIONAL JOURNAL OF RESEARCH AND applICATIONS 2017年第7期15卷 828-856页

作者： Pulkkinen, A. Bernabeu, E. Thomson, A. Viljanen, A. Pirjola, R. Boteler, D. Eichner, J. Cilliers, P. J. Welling, D. Savani, N. P. Weigel, R. S. Love, J. J. Balch, C. Ngwira, C. M. Crowley, G. Schultz, A. Kataoka, R. Anderson, B. Fugate, D. Simpson, J. J. MacAlester, M. NASA Goddard Space Flight Ctr Greenbelt MD 20771 USA PJM Valley Forge PA USA British Geol Survey Nottingham England Finnish Meteorol Inst Helsinki Finland Nat Resources Canada Ottawa ON Canada Munich Re Munich Germany South African Natl Space Agcy Pretoria South Africa Univ Michigan Dept Atmospher Ocean & Space Sci Ann Arbor MI 48109 USA Univ Maryland Baltimore Cty Goddard Planetary Heliophys Inst Baltimore MD 21228 USA George Mason Univ Dept Phys & Astron Fairfax VA 22030 USA US Geol Survey Golden CO USA NOAA Space Weather Predict Ctr Boulder CO USA Catholic Univ Amer Inst Astrophys & Computat Sci Washington DC 20064 USA Atmospher & Space Technol Res Associates LLC Boulder CO USA Oregon State Univ Inst Energy Resources & Resilience Corvallis OR 97331 USA Natl Inst Polar Res Tokyo Japan Johns Hopkins Univ Appl Phys Lab Laurel MD USA Elect Res & Management Inc Cabot PA USA Univ Utah Elect & Comp Engn Dept Salt Lake City UT USA Fed Emergency Management Assoc Washington DC USA

This paper is the primary deliverable of the very first NASA Living With a Star Institute Working Group, Geomagnetically Induced Currents (GIC) Working Group. The paper provides a broad overview of the current status and future challenges pertaining to the science, engineering, and applications of the GIC problem. Science is understood here as the basic space and Earth sciences research that allows improved understanding and physics-based modeling of the physical processes behind GIC. Engineering, in turn, is understood here as the "impact" aspect of GIC. applications are understood as the models, tools, and activities that can provide actionable information to entities such as power systems operators for mitigating the effects of GIC and government agencies for managing any potential consequences from GIC impact to critical infrastructure. applications can be considered the ultimate goal of our GIC work. In assessing the status of the field, we quantify the readiness of various applications in the mitigation context. We use the applications Readiness Level (ARL) concept to carry out the quantification.

关键词： geomagnetically induced currents space weather status of the field

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Evaluation of qPCR curve analysis methods for reliable biomarker discovery: Bias, resolution, precision, and implications

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METHODS 2013年第1期59卷 32-46页

作者： Ruijter, Jan M. Pfaffl, Michael W. Zhao, Sheng Spiess, Andrej N. Boggy, Gregory Blom, Jochen Rutledge, Robert G. Sisti, Davide Lievens, Antoon De Preter, Katleen Derveaux, Stefaan Hellemans, Jan Vandesompele, Jo Acad Med Ctr Dept Anat Embryol & Physiol NL-1100 AZ Amsterdam Netherlands Tech Univ Munich Ctr Life & Food Sci Weihenstephan D-80290 Munich Germany Univ Calif Berkeley Dept Psychol Berkeley CA 94720 USA Univ Calif Berkeley Helen Wills Neurosci Inst Berkeley CA 94720 USA Univ Hosp Hamburg Eppendorf Dept Androl Eppendorf Germany DNA Software Inc Ann Arbor MI 48104 USA Univ Bielefeld Ctr Biotechnol Bioinformat Resource Facil Bielefeld Germany Nat Resources Canada Laurentian Forestry Ctr Canadian Forest Serv Quebec City PQ G1V 4C7 Canada Univ Urbino Dept Biomol Sci I-61029 Urbino PU Italy Univ Ghent Dept Appl Math & Comp Sci B-9000 Ghent Belgium Univ Ghent Ctr Med Genet B-9000 Ghent Belgium Biogazelle Zwijnaarde Belgium

RNA transcripts such as mRNA or microRNA are frequently used as biomarkers to determine disease state or response to therapy. Reverse transcription (RT) in combination with quantitative PCR (qPCR) has become the method of choice to quantify small amounts of such RNA molecules. In parallel with the democratization of RT-qPCR and its increasing use in biomedical research or biomarker discovery, we witnessed a growth in the number of gene expression data analysis methods. Most of these methods are based on the principle that the position of the amplification curve with respect to the cycle-axis is a measure for the initial target quantity: the later the curve, the lower the target quantity. However, most methods differ in the mathematical algorithms used to determine this position, as well as in the way the efficiency of the PCR reaction (the fold increase of product per cycle) is determined and applied in the calculations. Moreover, there is dispute about whether the PCR efficiency is constant or continuously decreasing. Together this has lead to the development of different methods to analyze amplification curves. In published comparisons of these methods, available algorithms were typically applied in a restricted or outdated way, which does not do them justice. Therefore, we aimed at development of a framework for robust and unbiased assessment of curve analysis performance whereby various publicly available curve analysis methods were thoroughly compared using a previously published large clinical data set (Vermeulen et al., 2009) [11]. The original developers of these methods applied their algorithms and are co-author on this study. We assessed the curve analysis methods' impact on transcriptional biomarker identification in terms of expression level, statistical significance, and patient-classification accuracy. The concentration series per gene, together with data sets from unpublished technical performance experiments, were analyzed in order to assess the algo

关键词： qPCR curve analysis Transcriptional biomarker Bias Precision Resolution Benchmark

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General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy

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CLINICAL PHARMACOLOGY & THERAPEUTICS 2020年第1期107卷 102-111页

作者： Li, Zhihua Mirams, Gary R. Yoshinaga, Takashi Ridder, Bradley J. Han, Xiaomei Chen, Janell E. Stockbridge, Norman L. Wisialowski, Todd A. Damiano, Bruce Severi, Stefano Morissette, Pierre Kowey, Peter R. Holbrook, Mark Smith, Godfrey Rasmusson, Randall L. Liu, Michael Song, Zhen Qu, Zhilin Leishman, Derek J. Steidl-Nichols, Jill Rodriguez, Blanca Bueno-Orovio, Alfonso Zhou, Xin Passini, Elisa Edwards, Andrew G. Morotti, Stefano Ni, Haibo Grandi, Eleonora Clancy, Colleen E. Vandenberg, Jamie Hill, Adam Nakamura, Mikiko Singer, Thomas Polonchuk, Liudmila Greiter-Wilke, Andrea Wang, Ken Nave, Stephane Fullerton, Aaron Sobie, Eric A. Paci, Michelangelo Tshinanu, Flora Musuamba Strauss, David G. US FDA Div Appl Regulatory Sci Off Clin Pharmacol Off Translat SciCtr Drug Evaluat & Res Silver Spring MD 20993 USA Univ Nottingham Sch Math Sci Ctr Math Med & Biol Nottingham England Eisai & Co Ltd Global Cardiovasc Assessment Tokyo Japan US FDA Div Biometr 4 Off Biostat Off Translat SciCtr Drug Evaluat & Res Silver Spring MD USA US FDA Div Cardiovasc & Renal Prod Off Drug Evaluat 1 Off New DrugsCtr Drug Evaluat & Res Silver Spring MD USA Pfizer Inc Global Safety Pharmacol Groton CT 06340 USA Nonclin Safety Janssen Res & Dev Global Safety Pharmacol Raritan NJ USA Univ Bologna Dept Elect Elect & Informat Engn Cesena Italy Merck & Co Inc Dept Safety Assessment Kenilworth NJ USA Merck & Co Inc Lab Anim Resources Kenilworth NJ USA Main Line Hlth & Sidney Kimmel Med Coll Philadelphia PA USA Certara Ltd Sheffield S Yorkshire England Clyde Biosci Ltd Glasgow Lanark Scotland Glasgow Univ Inst Cardiovasc & Med Sci Glasgow Lanark Scotland SUNY Buffalo Jacobs Sch Med & Biomed Sci Dept Physiol & Biophys Buffalo NY USA Univ Calif Los Angeles Dept Med Div Cardiol Los Angeles CA 90024 USA Eli Lilly & Co Dept Toxicol & Pathol Indianapolis IN 46285 USA Covance Inc Madison WI USA Univ Oxford Dept Comp Sci Oxford England Univ Calif Davis Dept Pharmacol Davis CA 95616 USA Victor Chang Cardiac Res Inst Darlinghurst NSW Australia UNSW Sydney St Vincents Clin Sch Darlinghurst NSW Australia Chugai Pharmaceut Co Ltd Clin Pharmacol Dept Tokyo Japan F Hoffmann La Roche Ltd Roche Innovat Ctr Basel Roche Pharma Res & Early Dev Pharmaceut Sci Basel Switzerland F Hoffmann La Roche Ltd Safety Sci Licensing & Early Dev Roche Prod Dev Basel Switzerland Genentech Inc Dept Safety Assessment San Francisco CA 94080 USA Icahn Sch Med Mt Sinai New York NY 10029 USA Tampere Univ Fac Med & Hlth Technol BioMediTech Tampere Finland Fed Agcy Med & Hlth Prod Brussels Belgium European Medicines Agcy Amsterdam Netherlands

This white paper presents principles for validating proarrhythmia risk prediction models for regulatory use as discussed at the In Silico Breakout Session of a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/US Food and Drug Administration-sponsored Think Tank Meeting on May 22, 2018. The meeting was convened to evaluate the progress in the development of a new cardiac safety paradigm, the comprehensive in Vitro Proarrhythmia Assay (CiPA). The opinions regarding these principles reflect the collective views of those who participated in the discussion of this topic both at and after the breakout session. Although primarily discussed in the context of in silico models, these principles describe the interface between experimental input and model-based interpretation and are intended to be general enough to be applied to other types of nonclinical models for proarrhythmia assessment. This document was developed with the intention of providing a foundation for more consistency and harmonization in developing and validating different models for proarrhythmia risk prediction using the example of the CiPA paradigm.

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