Abstract The FDA modernization act 2.0, signed into law by President Biden in December 2022 encourages the use of alternatives to animal testing for drug discovery. Cell-based assays are one important alternative, however they currently not fit purpose. 3D, tissue engineered models represents a key development opportunity, enable human tissues and organs. However, much remains be done terms und...

FUNCTION Mass/energy flow and balance GENERAL FUNCTION Flow and storage of heat, etc. PHYSICAL FUNCTION States of components what? what? what? what? what?

(c) Copyright 2001 Sthamer, DaimlerChrysler AG • Introduction, Motivation • Evolutionary Algorithms • Evolutionary Testing (ET) and their Applications Evolutionary Safety Testing Evolutionary Structural Testing ➥ Experiments and Results Evolutionary Temporal-Behavior Testing ➥ Experiments and Results • Conclusion, Future Work 14th International Internet & Software Quality Week 2001 Evolutionary...

BACKGROUND The utility of defibrillation threshold testing in patients undergoing implantable cardioverter-defibrillator (ICD) implantation is controversial. Higher defibrillation thresholds have been noted in patients undergoing implantation of cardiac resynchronization therapy defibrillators (CRT-D). Since the risks and potential benefits of testing may be higher in this population, we sought...

Some dangerous failures of safety-instrumented systems (SISs) are detected almost immediately by diagnostic self-testing as dangerous detected (DD) failures, whereas other dangerous failures can only be detected by proof-testing, and are therefore called dangerous undetected (DU) failures. Some items may have a DUand a DD-failure at the same time. After the repair of a DD-failure is completed, ...

There has been an explosionof technology-enabled scientific insight into the basic biology of the causes of adverse events. This has been driven, in part, by the development of the various "omics" tools (e.g., genomics, proteomics, and metabolomics) and associated bioinformatics platforms. Meanwhile, for decades, changes in preclinical testing protocols and guidelines have been limited. Preclin...

1 The goal of testing is to make statements about the relation between the traces of an implementation and a temporal property. This is not possible for all temporal properties. Within this paper safety and guarantee properties are identi ed to be testable temporal properties and for these testable properties a test case de nition is given. This is done by representing a safety property as a la...

The objective of the RETHINK project was to evaluate the potential impact of toxicity testing in the minipig as an alternative approach in regulatory toxicity testing that can contribute to the replacement, refinement and reduction of animal testing (3Rs). Minipigs are strains of domestic pigs that are markedly smaller than farmyard varieties, and thus better adapted to laboratory housing. The ...