Preclinical safety testing is one important step in the development of new medicines. The requirements of such testing are the subject of government regulations and may vary in details, but not in general principles, in different countries around the world. The approach to preclinical safety testing of new drugs is multidisciplinary and requires the expertise of members from many different fiel...

Ambulance vehicles are a unique passenger environment with complex crashworthiness and occupant protection issues, eg. occupants in various orientations, unique human factors aspects and an array of aftermarket interior modifications. In the USA, ambulance vehicle occupant protection, crashworthiness and safety testing lags 30 years behind current general automotive safety technology. This pape...

Drug safety remains a high profile issue at a time when the cost and time required to develop a new drug are at an all time high. Balancing risk against the expected clinical benefit is the primary purpose of preclinical and clinical testing. We offer an expanded view on the application of predictive strategies and technologies to early safety decisions and suggestions to narrow the focus for i...

Learning-based testing (LBT) is a paradigm for fully automated requirements testing that combines machine learning with modelchecking techniques. LBT has been shown to be effective for unit and integration testing of safety critical components in cyber-physical systems, e.g. automotive ECU software. We consider the challenges faced, and some initial results obtained in an effort to scale up LBT...

Vent vacuum relief valves (VRVs) are used to limit the negative pressure at the ventricular vent catheter tip as well as prevent reversal of blood flow and prevention of air embolism. The purpose of this study was to evaluate the performance of three commercially available ventricular vent valves. The negative pressure at which the vent valve opened was measured at the valve inlet using high-fi...

Interactions between the laboratory and outpatient physician are critical to ensure the appropriateness, accuracy, and utility of laboratory results. A recent Institute of Medicine report suggested that the consequences of medical errors in the outpatient setting-and the opportunities to improve-"may dwarf those in hospitals." This article focuses on the role of the physician's office in labora...

Previous reports on the safety of exercise testing have been based on surveys from different testing facilities with a variety of testing protocols and patient types. From 1971 through 1987, 71,914 maximal exercise tests conducted in a population with a low prevalence of known coronary heart disease under uniform conditions at a single medical facility resulted in six major cardiac complication...

More than any other consumer product range, food represents an emotional issue with a strong cultural dimension. In a eurobarometer survey of 2002, 89% of the europeans interviewed considered food safety to be very important; interestingly 80% considered animal welfare to be very important in the same survey. Food also has an enormous economic impact on society, with the european food and drink...

The paper presents the experience of the authors in model based testing of safety critical real-time control logic software. It describes specifics of the corresponding industrial settings and discusses technical details of usage of UniTESK model based testing technology in these settings. Finally, we discuss possible future directions of safety critical software development processes and a pla...