Extrinsic safety

Work area - Ensuring extrinsic safety during complex decommissioning and environmental rehabilitation of radiation-hazardous facilities... 

The net result of these contradictory factors is that for all phosgenation reactions, by which we mean all reactions that can be achieved by the use of phosgene, all relevant intrinsic yield, reactivity, handling, work-up) and extrinsic safety,... 

Specifically designed sustainable phosgene substitutes for specific applications will be increasingly used (like the already used BOP, BDDC, CDC, and Burgess reagent see Chapter 4) to perform selective reactions that comply with the intrinsic yield, reactivity, handling, work-up) and extrinsic (safety, toxicity, environmental... 

A pharmacodynamic (PD) model describing the relationship between the observed concentration/exposure measure (e.g. the area under the plasma concentration-time profile AUC) and the observed drug effects on biomarkers, efficacy or safety measurements (or endpoints). Time dependent changes (e.g. development of tolerance) and influence of intrinsic and extrinsic factors should also be reflected in the model. 

Sodium cromoglicate is effective in extrinsic (allergic) asthma including asthma in children, and in exercise-induced asthma but its use has declined since the efficacy and safety of low dose inhaled corticosteroid have become apparent. 

A table, usually located in an appendix to a clinical safety subsection, is to list all deaths occurring while subjects/patients are on study, including deaths that occurred shortly following (e.g., within 30 days) treatment termination. Only deaths that are clearly disease-related as described in a clinical study protocol and are not related to the administration of a drug candidate can be excepted from this table. All deaths should be examined for any unexpected patterns between study treatment arms and further analyzed if unexplained differences are noted. Deaths are to be examined individually and analyzed on the basis of rates in individual clinical trials and appropriate pools of trials, considering both total mortality and cause-related deaths. Potential relationships of death to demographic, intrinsic, and extrinsic factors should also be considered. 

In the same time, we have to supplement the above shown parameters by parameters that characterize safety. The system must not cause by its action any possible dangerous conditions in its surroundings. The safety properties of the instrumentation and control system of industry processes (mechanical, electrical, etc.) depend on its own (intrinsic) system safety and on external (extrinsic) aspects on the protection included into the system. 

In this section, we show how the GSN patterns extension can be used to capture variation in the product-line safety case. A product-line safety case comprises reusable argument structures and evidence used as the basis for the definition of the safety case for each product derived from the product-line assets. Some of these argument structures and evidence are shared between all product safety cases, and therefore are core, while others differ from one product safety case to another, and therefore are variable. Generally, there are two types of product-line safety case variation intrinsic and extrinsic variation. 

Intrinsic variation exists whenever there is more than one argumentation style to support the safety claims of a particular product-line instance. Extrinsic variation, in contrast, is more peculiar to product-line safety cases. The source of this type of variation is not the product-line safety case itself but rather the reusable assets referenced in the safety case from product-line models such as the feature and reference architectural models. This is because many of these assets are expected to vary in how they are developed, configured and composed. This variation may change the contribution of these assets to safety and therefore may change the way in which the safety of the system is justified in the safety case. To this end, it is important that extrinsic... 

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