Test paradigms

More broadly, the evaluation of chemical cues is inherently more difficult than the evaluation of other sensory stimuli because the stimuli are difficult to control. Relative to visual or auditory cues, chemicals can not be applied with high precision (Lawless 1987). 

A variety of methods are available for the study of chemosensory abilities. 

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Another test paradigm for detecting treatment effects on brain functioning in Fj offspring measures auditory startle habituation. In this test, the animal is placed in a chamber with a floor that detects movement. The animal is exposed to a sequence of 50 to 60 auditory stimuli, each at 110 to 120 decibels for 20 to50 sec and separated by 5 to 20 sec. The gradual diminution of the animal s movement response is indicative of normal habituation. 

Exposure to a predator represents a test paradigm for anxiety (and panic, depending on the exact experimental design) that is receiving increased atten-... 

Martin MT, Knudsen TB, Judson RS, Kavlock RJ, Dix DJ (2012) Economic benefits of using adaptive predictive models of reproductive toxicity in the context of a tiered testing paradigm. Syst Biol Reprod Med 58 3-9... 

Our current regulatory testing paradigms are founded on in vivo testing that has been accepted as necessary and as the default, and based on an assumption of similar or identical biology and chemical response between the test species and humans. 

In the absence of existing human exposure data or other review of the excipient, FDA recommends in its guidance on Pharmaceutical Excipients (2) that the excipient be evaluated using a battery of standard nonclinical tests (7). Which tests are appropriate depends upon the likely patient exposure given the intended use of the drug if approved. Table 1 provides a summary of the necessary tests. This test paradigm will likely be considered as setting the standard for data requirements for any new excipients, whether or not approved by the FDA in an NDA or ANDA, or reviewed by some future alternative review/approval mechanism. 

Hill, R. G. Reply will changing the testing paradigms show that NK1 receptor antagonists are analgesic in humans Trends Pharmacol. Sci. 2000, 21, 465. 

The NovaScan has received substantial testing in a number of laboratory and applied settings. Performance on the NovaScan has been demonstrated to be sensitive to the effects of alcohol, marijuana, diazepam, amphetamine, scopolamine, and an over-the-counter antihistamine.6 59 60 In addition, epidemiological differences in performance associated with gender, age, and occupation have been considered. Variations of the testing paradigm have been used in a number of commercial settings. 

O Donnell, R.D., The NOVASCAN Test Paradigm Theoretical Basis and Validation, Nova Technologies, Inc, Dayton, OH, 1992. 

Evaluation of cognitive phenotypes of mouse models of neurodegeneration. These testing paradigms represent some of the most commonly used tests employed in behavioral evaluation of mouse models of neurodegenerative disease (Reprinted from (70) with permission)... 

TABLE 35.10 General preclinical development testing paradigms for a cell-based neo-organ product... 

Three other main test paradigms have been used that appear to expose the possible attentional dysfunction following manipulations of DA-ergic function latent inhibition prepulse inhibition and continuous performance (the five-choice serial reaction time task) - all notable for their correspondence to similar tests for human subjects. Curiously, the main emphasis of these investigations has been on mesolimbic rather than mesostriatal systems. 

Develop other revenue sources such as through acting as a platform company providing specific and proprietary services to the Pharma industry in diagnostic and testing paradigms. 

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