modeling and simulation of clinical trials an industry perspective

... articles offer advice on the designand analysis of clinical trials We group them here into three Chow S-C; Liu J-P (1998) Design and Analysis of Clinical Trials: Concept and Methodologies New York: ... matter of life and death? The Heart Protection Study and protection of clinical trial partici- pants Control Clin Trials 24:501–505; 585–588. Moore T (1995) Deadly Medicine: Why Tens of Thousands of ... Implementation of new Japanese GCP and the quality of clini-cal trials—from the standpoint of the pharmaceuticlini-cal industry Gan To Fazzari M; Heller G; Scher HI (2000) The phase II/III transition

Ngày tải lên: 14/08/2014, 07:20

... was notmade at random, and the treatments of control and experimentalsubjects were not contemporaneous, this type of design is not appro-priate for full-scale clinical trials They can be useful ... Randomized clinical-trials in the presence of diagnostic uncertainty—implications for measures of efficacy and sample- size Control Clin Trials 17:191–200. Cavan BN (1995) Improving clinical trials ... use of the common technical document or CTD has been mandatory inEurope and Japan and “highly recommended” by the FDA andHealth Canada Marketing may ask that you seek to publish your findings An

Ngày tải lên: 14/08/2014, 07:20

... Recruitment of physicians and the initial recruitment of patients should be brief and intense, concentrated in a few short weeks Ideally, training of the physician and his staff and appointment of a ... printed copy of your final report and an electronic copy of your database and the programs you’re used to retrieve and analyze the data In the United States, the latter is termed an e-sub or CANDA (Computer-Aided ... experiences of males and females, should be accompanied by a discussion of the statistical techniques employed and include measures of variability (23.2% ± 4.6%), of sample size (n = 323), and of statistical

Ngày tải lên: 14/08/2014, 07:20

... [...]... management software and the options available to you 2 Transfer of data from data entry to data storage and from data storage to your report generating and statistical analysis ... descriptions of the usage, structure, contents and attributes of all data sets and variables • Allow reviewers to replicate most analyses, tables, graphs, and listings with minimal or no transformations, ... statistical analysis software 3 Maintaining the security and integrity of your data OPTIONS Flat Files Many managers would feel more comfortable if clinical data could be stored and viewed in

Ngày tải lên: 14/08/2014, 07:20

... conductedvia the Web, new data management methods and software may berequired See, for example, Brandt et al (2000) and Wübbelt, Fernandez, and Heymer (2000) QUALITY ASSURANCE AND SECURITY Maintaining ... Although the ability to write to and modify a clinical database can and should be restricted to a privileged and responsible (and readily CHAPTER 11 DATA MANAGEMENT 155 Trang 6monitored) few, everyone ... effort See Gandy (2001) and Mendes (1995). Mike Chuck Statistician y y Seri Shanti Programmer y y y Trang 8copies in a remote location Standard practice is the cycle of 3 times 5, and sometimes

Ngày tải lên: 14/08/2014, 07:20

... example, Slud and Wei (1982), DeMets and Lan (1984), Siegmund (1985), and Mehta et al. (1994). A WORD OF CAUTION OF SPECIAL INTEREST TO CUBS FANS 38 He later broke several. In any event, observations ... Format and Content of the Clinical and Statistical Sections of an Application may be downloaded from http://www.fda.gov/cder/guidance/statnda.pdf The purpose of the statistical analysis ... Committee members require the same sort of procedure manuals and the same sort of follow-ups as investigators. TERMINATION AND EXTENSION Several stages and many individuals are involved in decisions

Ngày tải lên: 14/08/2014, 07:20

... sexualdifferences, and to testing for a common odds ratio.Estimating Precision Reporting results in terms of a mean and standard error as in 56 ±3.2 is a long-standing tradition Indeed, many members of regulatorycommittees ... logarithms of the observa-tions, computes the mean and standard error of the logarithms anddetermines a symmetric confidence interval One then takes theantilogarithms of the boundaries of the confidence ... minimum, maximum and median are 137.0, 167.5 and 148.5,respectively The medians of fifty bootstrapped samples drawn from our sampleranged between 142.25 and 158.25 with a median of 152.75 (see

Ngày tải lên: 14/08/2014, 07:20

... American College of Physicians Schultz KF; Chalmers I; Grimes DA; Altman DG (1994) Assessing thequality of randomization from reports of controlled trials published in journals of obstetrics and ... schedule specification and tracking, including the identification of missing and late (CRFs), manage and track treat- ment blind breaks, and track patient availability and withdrawal information. ... personnel and warehouse for all trial data and Trang 9records Data entry includes range and logic checks ClinicalTrialsNet Inc, 12 John Street, Charleston, SC 29403, 843.965.5598,info@clinicaltrialsnet.com.

Ngày tải lên: 14/08/2014, 07:20

... addition, results of position measurement and noise analysis of the capacitive accelerometer are given Chapter 3 focuses on modeling and simulation of different structures using SUGAR language in MATLAB ... rin g ” and the “ electrical dum per” R earranging the equation, w e can obtain: Trang 32Again, the mechanical spring and damping are usually dominated by their electric counterparts and can be ... the voltage and proof mass’s displacement of theFigure 3.14 Relation between voltage and acceleration of two parallel beams Figure 3.16 Relation between voltage and acceleration of the four symmetric

Ngày tải lên: 25/03/2015, 11:44

... the concept of virtual reality (VR) and computer haptics; the surface-based and volume-based modeling approach of virtual objects; haptic rendering methods; and the current state of VR and haptic ... Micro-implants and Micro-implants Surgery 2 1.2 Motivation 3 1.3 Research Objectives and Scope 4 1.4 Organization of the Thesis 6 CHAPTER 2 LITERATURE REVIEW 8 Trang 52.1 Virtual Reality and Computer ... drilling and screwing of micro-implants; and (iii) stop in time when further screwing might cause the stripping of the implants To achieve these goals, the haptics-based geometry and force modeling

Ngày tải lên: 09/09/2015, 10:07

... Trang 1MODELING AND SIMULATION OF BUCKLING OF PRISTINE AND DEFECTIVE CARBON NANOTUBES D D THANUJA KRISHANTHI KULATHUNGA (B.Eng.(Hons.), University of Moratuwa, Sri Lanka) A THESIS ... buckling of defective freestanding CNTs Here, effects of different defect parameters, such as number of missing atoms, number of dangling bonds, asymmetry of defects and number of vacancy Trang 28the ... directions relevant to the present study Trang 29an important issue in the design of NEMS (Nanoelectromechanical Systems) and sensors where mechanical, optical and electrical properties of CNTs are

Ngày tải lên: 09/09/2015, 18:54

... somereview papers[21] An important landmark in the development of quantum mechanical theory of superconducting transport is the experimental determination of the individualquantum channels of a superconducting ... electromechanicals[ 8 ] and electronic devices[ 9 , 10 ] An overview of itsbasic properties is available in many good review articles and books[ 11 ], and we Trang 15shall only discuss some relevant ... corners of the department who helped me in many occasions, the staff,friends and for those who taught me many advanced topics in physics Last butnot least, I thank Prof Chong Kim Ong and Prof Dagomir

Ngày tải lên: 10/09/2015, 15:48

... MODELING AND SIMULATION OF ANTISOLVENT CRYSTALLIZATION: MIXING AND CONTROL WOO, XING YI NATIONAL UNIVERSITY OF SINGAPORE & UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN 2007 MODELING AND SIMULATION ... understanding of the crystallization process of different.. .Modeling and Simulation of Antisolvent Crystallization: Mixing and Control theoretical development and analysis of ... National i Modeling and Simulation of Antisolvent Crystallization: Mixing and Control Center for Supercomputing Applications (NCSA) in Illinois and the Institute of Chemical and Engineering

Ngày tải lên: 14/09/2015, 09:18

... axis and applied field are coaxial as in Fig 2.5 33 Fig 2.7 Gilbert equation resultant dt d M and its relationship to rate of change of polar angleθ and azimuthal angleϕ 34 Fig 2.8 Mallinson analytical ... dependency of transition parameters, crosstrack correlation length and transition noise parameters 184 Fig 8.15 Exchange dependency of transition parameter and transition noise parameter with anisotropy ... 10% and 20% 185 Fig 8.16 Exchange dependency of transition parameter and transition noise parameter with magnetization saturation distribution being 3%, 10% and 20% case 186 Trang 20List of Symbols

Ngày tải lên: 15/09/2015, 17:10

... Trang 1MULTI-AGENT BASED MODELING AND SIMULATION OF METABOLIC NETWORKS MOHAMMAD IFTEKHAR HOSSAIN NATIONAL UNIVERSITY OF SINGAPORE 2008 Trang 2MULTI-AGENT BASED MODELING AND SIMULATION OF ... such kind of modeling and simulation tools is substantially important The focus of modeling in cell physiology has always been on the understanding of metabolic systems in the sense of the general ... where modeling and simulation can contribute significantly: • Understanding the system: Mathematical models are the quantitative representation of knowledge with the ability to have a unique and

Ngày tải lên: 26/11/2015, 13:02

... [208], [209], and the extensive works of Farhat and coworkers (Piperno et al [163], Farhat et al [65], Lesoinne and Farhat [130], Farhat and Lesoinne [66], Piperno and Farhat [163], and Farhat et ... size of t lim = 10−2 s and a starting time step size of 10−3 s The tolerances of both fields (TOLr and TOLθ ) for the fixed-point iterations were set to 10−6 and the upper limit on the number of ... radius of analyticity of a Taylor series expansion of the solution around time t, which converges in a ball of radius from the point of expansion to the nearest singularity in Equations (7.55) and...

Ngày tải lên: 06/08/2014, 01:21

... mechanical forces and heat transfer induced by the fluid on the particles and vice versa Because the coupling of the various particle and fluid fields can dramatically change over the course of a ... see Berlyand and Panchenko [30] and Berlyand et al [31] Although not employed here, discrete network approximations appear to be quite attractive for possibly improving the description of the interaction ... balance, governing the interconversions of mechanical, thermal, and chemical energy in a system, dictated by the first law of thermodynamics Accordingly, we require the time rate of change of...

Ngày tải lên: 06/08/2014, 01:21

... particle-laden and bubble-laden fluids (Ferrante and Elghobashi [68], Ahmed and Elghobashi [2], [3], and Druzhinin and Elghobashi [60]) Also, as mentioned earlier, improved descriptions of the fluid-particle ... Bohren and Huffman [33] and van de Hulst [195] Remark An application of particular interest, where scattering calculations can play a supporting role, is the investigation of clustering and aggregation ... interaction can possibly be achieved by using discrete network approximations, which account for hydrodynamic interactions such as those of Berlyand and Panchenko [30] and Berlyand et al [31]...

Ngày tải lên: 06/08/2014, 01:21

... variety of such methods, employing concepts of species evolution such as reproduction, mutation, and crossover Such methods primarily stem from the work of John Holland (Holland [94]) For reviews of ... violet and blue light of shorter wavelengths is bent more than the orange and red light of longer wavelengths.68 Thus, dispersive effects introduce a new level of complexity, primarily because of ... research efforts in both industry and academia For a review of CMP practice and applications, see Luo and Dornfeld [143]–[146] It is clear that for the process to become viable and efficient, the underlying...

Ngày tải lên: 06/08/2014, 01:21

... ||∇F || The orientation of the cells, usually random, can be controlled, via standard rotational coordinate transformations, with random angles (Figure B.4) The classical random sequential addition ... response of large numbers of randomly distributed and oriented RBCs Because the diameter of a typical RBC is on the order of eight microns (d ≈ × 10−6 m), which is much larger than the wavelengths of ... For details, see Coleman and Saunders [47], Kim [124], Pittomvils et al [165], Kahn et al [116], Kahn and Hackett [117], [118], and Zohdi and Szeri [222] Clearly, the number of applications in the...

Ngày tải lên: 06/08/2014, 01:21