Evidence design features

While the presentation thus far has emphasized the programmed relationship of hapten design and consequent antibody catalytic activity, there is a growing number of examples where the detailed examination of catalysis reveals mechanistic features that were not evidently design features of the system at the outset. Such discoveries are clearly a strength rather than a weakness of... 

If these research design features had been mandatory, this chapter would be exceedingly short. Thankfully, undaunted researchers have collected a substantial amount of data that, when pressed against the filter of scientific rigor, yields at least indirect evidence. Still, there are times when indirect evidence is quite ample and convincing (e.g., Einstein s Theory of Special and General Relativity). 

Design features intended to mitigate risk often make up strong controls and their verified presence and effectiveness constitute valuable evidence. 

The majority of the supporting analysis and evidence that radiation protection has been considered in the AP1000 design is contained in Chapters 11 and 12 of the APIOOO European Design Control Document (EDCD) (Reference 12.1). This includes the design features that have been incorporated to minimise the necessity for and the amount of time spent in a radiation area. 

This type of distribution of roles between heterotypic induction (a common plan of structure) and homotypic (fabrication of the details) is evidently a feature of the design of any complex structure. When a building is constructed, a basic plan is first produced, and then special drawings are made for the larger and smaller details of the rooms independently. 

Objective evidence of the achieved features and characteristics of a product or service and the processes applied to its development, design, production, installation, maintenance, and disposal as well as records of assessments, audits, and other examinations of an organization to determine its capability to achieve given quality requirements. 

As part of the design proeess, it is neeessary to inelude features in the formulation and delivery system to provide as mueh proteetion as possible against microbial eontaminahon and spoilage. Beeause of potenhal toxicity and irritancy problems, anhmicrobial preservatives should only be considered where there is clear evidence of posihve benefit. Manipulahon of physico-chemical parameters, such as A, the eliminahon of particularly suscephble ingredients, the selection of a preservahve or the choice of container may contribute significantly to overall medicine stability. 

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