Testing strategy

Overview of the non-clinical testing strategy Pharmacology Pharmacokinetics Toxicology... 

In the summary of the aforementioned report, the authors recommend, as did earlier reviewers of this subject, the development and evaluation of a tiered testing strategy for neurotoxicity. The further development of in vitro models for establishing mechanisms of neurotoxicity should be part of this strategy. Full consideration should also be given to advances in the omics and other technological fields. 

Interest has been expressed in the possibility of using biomarker assays as a part of risk assessment for regulatory purposes, and some workers have suggested tiered testing procedures that follow this approach (see, for example, Handy et al. 2003). It is to be hoped that regulatory schemes, such as that of REACH (see European Union 2003), will be sufficiently flexible to incorporate new assays and testing strategies as the science advances. 

Gray, L.E. (1998). Tiered screening and testing strategy for xenoestrogens and antiandrogens. Toxicology Letters 103, 677-680. 

Traditionally, libraries of enzymes - either naturally occurring or deliberately created mutants - are created in bacterial cells and the resulting clones are screened (Fig. 2, left). This is a time-tested strategy, but it suffers from two... 

Some examples are given below to illustrate extraction procedures for proteins that have been optimized for different matrices and testing strategies. 

Where needed, document the testing strategy that should be conducted for each system function. 

Sprague GL, Castles TR, Bickford AA. 1984. Assessment of the delayed neurotoxic potential of isopropyl triphenylphosphate using a nontraditional testing strategy. Toxicol Environ Health 14 773-788. 

An important point made by the ECVAM is that these three aspects should not be considered as alternatives that could replace each other, but as parts of an integrated system which should lead to progress in the development of non-animal tests and testing strategies. 

The possible use of the BALB/c 3T3 CTA is mentioned in various recent testing strategies including the supplemental data for pharmaceuticals and the guidance on information requirements and chemical safety assessment for REACH [34, 35]. 

NRC (National Research Council). 1984d. Toxicity Testing Strategies to Determine Needs and Priorities. Washington, DC National Academy Press. 

The main subject of this chapter is the identification of hazardous chemicals, materials, mixtures, and reaction masses. The chapter deals with undesired decompositions and hazardous reactions. A basic knowledge of the chemistry involved, and, in particular, with the thermodynamics and kinetics, is required. Furthermore, it is important to have a test strategy to recognize and assess the hazards associated with the energetic materials, mixtures, and reaction masses. 

Example 4 A Stability/Runaway Hazard Assessment Report In Table 2.3, test data evaluating stability/runaway hazards of a material are presented. This table contains the relevant test data and evaluations in accordance with Section 2.1.5 (Test Strategies) and represents a good model for summary reports of such key information. 

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