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Quality, simulation, reliability, system engineering

Kai Mattern, Nicole Beißner, Stephan Reichl, Andreas Dietzel
Conventional safety and efficacy test models, such as animal experiments or static in vitro cell culture models, can often not reliably predict the most promising drug candidates. Therefore, a novel microfluidic cell culture platform, called Dynamic Micro Tissue Engineering System (DynaMiTES), was designed to allow online analysis of drugs permeating through barrier forming tissues under dynamic conditions combined with monitoring of the transepithelial electrical resistance (TEER) by electrodes optimized for homogeneous current distribution...
May 2018: European Journal of Pharmaceutics and Biopharmaceutics
Yuki Imaizumi, Tatsuro Goda, Daniel F Schaffhauser, Jun-Ichi Okada, Akira Matsumoto, Yuji Miyahara
The membrane integrity of live cells is routinely evaluated for cytotoxicity induced by chemical or physical stimuli. Recent progress in bioengineering means that high-quality toxicity validation is required. Here, we report a pH-sensitive transistor system developed for the continuous monitoring of ion leakage from cell membranes upon challenge by toxic compounds. Temporal changes in pH were generated with high reproducibility via periodic flushing of HepG2 cells on a gate insulator of a proton-sensitive field-effect transistor with isotonic buffer solutions with/without NH4 Cl...
March 1, 2017: Acta Biomaterialia
Andrea Simonetti, Filippo Amari
UNLABELLED: In reaction to the limitations of the traditional sterility test methods, in 2008, the U.S. Food and Drug Administration issued the guidance "Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products" encouraging sterile drug manufacturers to use properly validated physical methods, apart from conventional microbial challenge testing, to confirm container closure integrity as part of the stability protocol...
January 2015: PDA Journal of Pharmaceutical Science and Technology
Shinya Tasaki, Ben Sauerwine, Bruce Hoff, Hiroyoshi Toyoshiba, Chris Gaiteri, Elias Chaibub Neto
Reconstructing biological networks using high-throughput technologies has the potential to produce condition-specific interactomes. But are these reconstructed networks a reliable source of biological interactions? Do some network inference methods offer dramatically improved performance on certain types of networks? To facilitate the use of network inference methods in systems biology, we report a large-scale simulation study comparing the ability of Markov chain Monte Carlo (MCMC) samplers to reverse engineer Bayesian networks...
April 2015: Genetics
S Nasso, J Hartler, Z Trajanoski, B Di Camillo, K Mechtler, G M Toffolo
UNLABELLED: Mass spectrometry-based proteomics can generate highly informative datasets, as profile three-dimensional (3D) LC-MS data: LC-MS separates peptides in two dimensions (time, m/z) minimizing their overlap, and profile acquisition enhances quantification. To exploit both data features, we developed 3DSpectra, a 3D approach embedding a statistical method for peptide border recognition. 3DSpectra efficiently accesses profile data by means of mzRTree, and makes use of a priori metadata, provided by search engines, to quantify the identified peptides...
January 1, 2015: Journal of Proteomics
Richard W Pew
OBJECTIVE: I provide a summary that introduces three significant threads in the development of human performance models (HPMs) - manual control models derived from engineering control theory, network models founded on the definition of human reliability, and models derived from cognitive architectures. BACKGROUND: HPMs are important because they allow the quantification of human performance capacities and limitations to be included in the analysis and simulation of engineering systems...
June 2008: Human Factors
L Benedetti, D Bixio, P A Vanrolleghem
Process choice and dimensioning of WWTPs is a particularly sensitive step to cost-efficiently comply with regulatory standards. This step accounts only for a small fraction of the upfront costs, but it can lead to substantial savings. This paper illustrates the results of a systematic methodology to evaluate system design/upgrade options. In contrast to conventional practice, this approach allows the choice between the most appropriate trade-off between cost of measures and effluent quality, and to assess the reliability of a process layout...
2006: Water Science and Technology: a Journal of the International Association on Water Pollution Research
Zheng Yi Wu
A water quality model is to predict water quality transport and fate throughout a water distribution system. The model is not only a promising alternative for analyzing disinfectant residuals in a cost-effective manner, but also a means of providing enormous engineering insights into the characteristics of water quality variation and constituent reactions. However, a water quality model is a reliable tool only if it predicts what a real system behaves. This paper presents a methodology that enables a modeler to efficiently calibrate a water quality model such that the field observed water quality values match with the model simulated values...
2006: Journal of Environmental Science and Health. Part A, Toxic/hazardous Substances & Environmental Engineering
Gert Zülch, Jan Krüger, Hermann Schindele, Sven Rottinger
This paper presents research activities associated with the development of a simulation tool for modelling human reliability in production systems. This dynamic model enables the planner to determine the consequences of changes in human reliability on the quality of the production processes and the products. The model is built upon the basis of a tool for human reliability analysis ESAT (Experten-System zur Aufgaben-Taxonomie; Aufgabentaxonomie: Ein Verfahren zur Ermittlung der menschlichen Leistung bei der Durchführung von Aufgaben, Messerschmitt-Bölkow-Blohm, Ottobrunn, 1990...
July 2003: Applied Ergonomics
T Wijtzes, K van't Riet, J H Huis in't Veld, M H Zwietering
The development of a method to predict microbial food safety and quality is described. The manufacture of a food from its ingredients is simulated, using a recipe. Food engineering heuristics are combined with models developed in predictive microbiology. Parameter values of ingredients of foods, such as water activity and pH, and models for microbial growth and decay are used for the prediction of the kinetics of microorganisms generally found in ingredients. The values of these parameters are collected in databases...
June 30, 1998: International Journal of Food Microbiology
Y T Chang, G H Loew
The purpose of this work was to develop and carefully evaluate improved strategies for constructing reliable 3-D models of P450 isozymes. To this end, a unique combination of steps for building and evaluating a model structure was used to build a homology model of the P450choP isozyme, based on knowledge of the X-ray structures of P450cam, P450terp, P450BM-3 and P450eryF. Specifically, the reliability of this model was examined by systematic comparisons of its conformational, energetic, environmental and packing properties and those of the four reference proteins with corresponding properties from the database of proteins with known structures...
September 1996: Protein Engineering
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