Barbara Wisniowska

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Drug cardiotoxicity is one of the main reasons of fatal drug related problem events and the subsequent withdrawals. Therefore, its early assessment is a crucial element of the drug development process. For the drug driven hERG inhibition assessment, which is assumed to be the main reason for toxicity, in vitro techniques are used. Gold standards are based(More)
SUMMARY The BDTcomparator facilitates the selection of the best performing binary classification model or binary diagnostic procedure from the many possible alternatives by comparing their predictions with a known output, measured with the use of a system recognized as the gold standard. The program calculates the estimates of accuracy, sensitivity,(More)
Drugs safety issues are now recognized as being factors generating the most reasons for drug withdrawals at various levels of development and at the post-approval stage. Among them cardiotoxicity remains the main reason, despite the substantial effort put into in vitro and in vivo testing, with the main focus put on hERG channel inhibition as the(More)
Proarrhythmia assessment is one of the major concerns for regulatory bodies and pharmaceutical industry. ICH guidelines recommending preclinical tests have been established in attempt to eliminate the risk of drug-induced arrhythmias. However, in the clinic, arrhythmia occurrence is determined not only by the inherent property of a drug to block ion(More)
The study aimed to assess the usefulness of the modeling and simulation approach for the proarrhythmic potency of the non-cardiological drugs prediction. Ability to mimic population effect with use of the virtual population generator on the QTc value was tested. ToxComp version 1.5 (www.tox-comp.net) with ten Tuscher human cardiomyocyte model (1D string(More)
The purpose of this work was to develop a mathematical model of the drug dissolution (Q) from the solid lipid extrudates based on the empirical approach. Artificial neural networks (ANNs) and genetic programming (GP) tools were used. Sensitivity analysis of ANNs provided reduction of the original input vector. GP allowed creation of the mathematical(More)
The project aims to develop the systems biology driven, modeling and simulation based, easy to use for non-modelers platform for the drugs proarrhythmic potency assessment at the population level. Platform realizes the in vitro-in vivo extrapolation approach thus the input data comes from the patch clamp in vitro ionic currents inhibition studies.(More)
The aim of the study was to simulate the possible clinical situation of the drug overdose and to assess its electrophysiological consequences, and thus to move the M&S approach to the patient's bedside level. Cardiological consequences of citalopram overdose were simulated with use of the ToxComp system. Physiology of the 36-yo woman, 33 hours post(More)
Cardiac safety is an issue causing early terminations at various stages of drug development. Efforts are put into the elimination of false negatives as well as false positives resulting from the current testing paradigm. In silico approaches offer mathematical system and data description from the ion current, through cardiomyocytes level, up to(More)