TESTING FRAMEWORK

As was the case with tier testing, developmental immunotoxicology has been driven by expert workshops to reach consensus on the most important issues three workshops were held in 2001 [79-81], and another in 2003 [82], These workshops contributed to the development of a proposed testing framework to detect developmental immunotoxicity, which is described in detail in chapter 21. 

EPA Science Forum DIT A proposed testing framework Washington, DC May, 2005... 

Specifications can be written not only as pictorial models but also in the form of executable test frameworks. The benefit is a much stronger assurance of conformance, especially where there may be a variety of candidate implementations. 

CDRH (1997). Immunotoxicology Testing Framework, Draft Document., U.S. Department of Health and Human Services, Washington, D.C. 

We will focus our attention to the situation of non-inferiority. Within the testing framework the type I error in this case is as before, the false positive (rejecting the null hypothesis when it is true), which now translates into concluding noninferiority when the new treatment is in fact inferior. The type II error is the false negative (failing to reject the null hypothesis when it is false) and this translates into failing to conclude non-inferiority when the new treatment truly is non-inferior. The sample size calculations below relate to the evaluation of noninferiority when using either the confidence interval method or the alternative p-value approach recall these are mathematically the same. 

Managers in the sample were asked to relate their experience directly to the model, which they were all apparently able to do. The model thus provides a tested framework which other managers can use to help make sense of their past experience and see the direction in which they need to develop in the future. 

Figure 7.1 Testing framework for surfactants in washing, rinsing and cleaning products prior to the Detergents Regulation.

Figure 7.2 Schematic testing framework and documentation for surfactants in detergent products following the Detergent Regulation. ...

Chapter 5 Systems framework and Chapter 6 Testing framework ... 

Holsapple MP, Burns-Naas LA, Hastings KL, Ladies GS, Lavin AL, Makris SL et al (2005) A proposed testing framework for developmental immunotoxicology (DIT). Toxicol Sci 83 18-24... 

Rirther extensions deal with code generation. The generated code allows the execution of specified services. It is embedded into a test framework to interactively evaluate and explore the specified services. This test framework is comparable with the tool support to explore existing component interfaces interactively (cf. Subsect. 5.7.4). 

P. Hamill, Unit Test Frameworks. O Reilly, Sebastopol, CA, 2004. 

The hypothesis testing framework described above is basically the system proposed by J. Neyman and E. Pearson (see Chapter 2). It can be regarded as the official modern frequentlst approach to clinical trials. In practice, an older approach due to R.A. Fisher (see Chapter 2) is often used. 

Monitoring for safety presents statistically difficult problems. In looking for safety signals, the DMC searches for the unknown, the rare unexpected event. Problems of multiplicity abound—many outcomes and many looks conspire to muddle the sample space and therefore make probabilities ill defined. While one can, and should, specify precisely the number of outcomes to evaluate for efficacy, by definition one carmot specify the number of hypotheses relevant to safety. Instead, the DMC must remain alert to react to surprises, turning a fundamentally hypothesis-generating ("data dredging") exercise into somewhat of a hypothesis-testing framework. 

This type of testing is used by TTS developers to help them improve specific aspects or components of the system they are working on [517]. Each system will of course have its own set of components and hence we can t provide a single exhaustive testing framework which will encompass all systems. We can however identify several important areas in which testing can take place. 

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