Browsing by Keyword "Validation"
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Item Development and validation of a bioanalytical method for the simultaneous determination of heroin, its main metabolites, naloxone and naltrexone by LC–MS/MS in human plasma samples: Application to a clinical trial of oral administration of a heroin/naloxone formulation(ELSEVIER SCIENCE BV, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDS, 2015-10-10) Moreno-Vicente, Raquel; Fernandez-Nieva, Zuriñe; Navarro-Alvarez, Arantza; Gascon-Crespi, Irene; Farre-Albaladejo, Magi; Igartua, Manuela; Hernandez, Rosa Maria; Pedraz, Jose LuisA bioanalytical method using high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) was developed and validated for simultaneous quantification of heroin, its main metabolites and naloxone. In addition, naltrexone was detected qualitatively. This method was used to analyse human plasma samples from a clinical trial after oral administration of a heroin/naloxone formulation in healthy volunteers. O-methylcodeine was used as an internal standard. Samples were kept in an ice-bath during their processing to minimize the degradation of heroin. A short methodology based on protein precipitation with methanol was used for sample preparation. After protein precipitation, only the addition of a formic acid solution was needed to elute heroin, 6-monoacetylmorphine, morphine, naloxone and naltrexone. Morphine metabolites were evaporated to dryness and reconstituted in a formic acid solution. Chromatographic separation was achieved at 35 C on an X-Bridge Phenyl column (150 x 4.6 mm, 5 mu m) using a gradient elution with a mobile phase of ammonium formate buffer at pH 3.0 and formic acid in acetonitrile. The run time was 8 min. The analytes were monitored using a triple quadrupole mass spectrometer with positive electrospray ionization (ESI+) in multiple reaction monitoring (MRM) mode. The method was found to be linear in a concentration range of 10-2000 ng/mL for M3G and 10-1000 ng/mL for the rest of compounds. Quality controls showed accurate values between -3.6% and 4.0% and intra- and inter-day precisions were below 11.5% for all analytes. The overall recoveries were approximately 100% for all analytes including the internal standard. A rapid, specific, precise and simple method was developed for the determination of heroin, its metabolites, naloxone and naltrexone in human plasma. This method was successfully applied to a clinical trial in 12 healthy volunteers.Item ERIGrid Holistic Test Description for Validating Cyber-Physical Energy Systems(2019-07-16) Heussen, Kai; Steinbrink, Cornelius; Abdulhadi, Ibrahim F.; Nguyen, Van Hoa; Degefa, Merkebu Z.; Merino, Julia; Jensen, Tue V.; Guo, Hao; Gehrke, Oliver; Bondy, Daniel Esteban Morales; Babazadeh, Davood; Pröstl Andrén, Filip; Strasser, Thomas I.; Van Hoa, Nguyen; Tecnalia Research & InnovationSmart energy solutions aim to modify and optimise the operation of existing energy infrastructure. Such cyber-physical technology must be mature before deployment to the actual infrastructure, and competitive solutions will have to be compliant to standards still under development. Achieving this technology readiness and harmonisation requires reproducible experiments and appropriately realistic testing environments. Such testbeds for multi-domain cyber-physical experiments are complex in and of themselves. This work addresses a method for the scoping and design of experiments where both testbed and solution each require detailed expertise. This empirical work first revisited present test description approaches, developed a newdescription method for cyber-physical energy systems testing, and matured it by means of user involvement. The new Holistic Test Description (HTD) method facilitates the conception, deconstruction and reproduction of complex experimental designs in the domains of cyber-physical energy systems. This work develops the background and motivation, offers a guideline and examples to the proposed approach, and summarises experience from three years of its application.Item OC5 Project Phase II: Validation of Global Loads of the DeepCwind Floating Semisubmersible Wind Turbine: Validation of Global Loads of the DeepCwind Floating Semisubmersible Wind Turbine(2017-10) Robertson, Amy N.; Wendt, Fabian; Jonkman, Jason M.; Popko, Wojciech; Dagher, Habib; Gueydon, Sebastien; Qvist, Jacob; Vittori, Felipe; Azcona, José; Uzunoglu, Emre; Soares, Carlos Guedes; Harries, Rob; Yde, Anders; Galinos, Christos; Hermans, Koen; de Vaal, Jacobus Bernardus; Bozonnet, Pauline; Bouy, Ludovic; Bayati, Ilmas; Bergua, Roger; Galvan, Josean; Mendikoa, Iñigo; Sanchez, Carlos Barrera; Shin, Hyunkyoung; Oh, Sho; Molins, Climent; Debruyne, Yannick; RENOVABLES OFFSHOREThis paper summarizes the findings from Phase II of the Offshore Code Comparison, Collaboration, Continued, with Correlation project. The project is run under the International Energy Agency Wind Research Task 30, and is focused on validating the tools used for modeling offshore wind systems through the comparison of simulated responses of select system designs to physical test data. Validation activities such as these lead to improvement of offshore wind modeling tools, which will enable the development of more innovative and cost-effective offshore wind designs. For Phase II of the project, numerical models of the DeepCwind floating semisubmersible wind system were validated using measurement data from a 1/50th-scale validation campaign performed at the Maritime Research Institute Netherlands offshore wave basin. Validation of the models was performed by comparing the calculated ultimate and fatigue loads for eight different wave-only and combined wind/wave test cases against the measured data, after calibration was performed using free-decay, wind-only, and wave-only tests. The results show a decent estimation of both the ultimate and fatigue loads for the simulated results, but with a fairly consistent underestimation in the tower and upwind mooring line loads that can be attributed to an underestimation of waveexcitation forces outside the linear wave-excitation region, and the presence of broadband frequency excitation in the experimental measurements from wind. Participant results showed varied agreement with the experimental measurements based on the modeling approach used. Modeling attributes that enabled better agreement included: the use of a dynamic mooring model; wave stretching, or some other hydrodynamic modeling approach that excites frequencies outside the linear wave region; nonlinear wave kinematics models; and unsteady aerodynamics models. Also, it was observed that a Morison-only hydrodynamic modeling approach could create excessive pitch excitation and resulting tower loads in some frequency bands.Item OES Task 10 WEC heaving sphere performance modelling verification(CRC Press, 2018-09-12) Nielsen, K.; Wendt, F.; Yu, Y.-H.; Ruehl, K.; Touzon, Imanol; et al.OES Task 10 Modelling, Verification and Validation of Wave Energy Converters (WECs) is a task under the IEA Technology Collaboration Program for Ocean Energy Systems (OES). The long-term goals are to assess the accuracy of, and establish confidence in, the use of numerical WEC models, to determine a range of validity of existing computational modelling tools, to identify uncertainty related to simulation meth-odologies and finally to define future research. To some extent, this project builds on the experience from a similar effort carried out to verify modelling of wind turbines as part of the IEA Wind Task 30 on wind OC3-OC5.