Battery of tests

In a battery of tests, which determine the tendency of chemicals to inhibit aquatic organisms, accumulate in such organisms, and degrade in the environment, 2-hydroxy-2-nitro-l,3-propanediol was found to have low potential for harm in the environment (7). 

EinaHy, the ecotoxicological studies, designed to assess the impact of the substance on the environment, embrace acute toxicity tests to fish and Daphnia, and a battery of tests for the biodegradabiUty of the substance and its biological oxygen demand characteristics. 

Screening for the numerous disease of genetic origin on newborns will be expanded so that eventually a battery of tests will be utilized for the determination of the erythrocyte abnormalities and abnormalities of intermediate metabolism. 

For processes under development, the most cost-effective means of avoiding potential risk is to eliminate those materials that are inherently unsafe that is, those materials whose physical or physico-chemical properties lead to them being highly reactive or unstable. This is somewhat difficult to achieve for several reasons. First, without a full battery of tests to determine, for example, flammability, upper/lower explosivity limits and their variation with scale, minimum ignition temperatures, and so on, it is almost impossible to tell how a particular chemical will behave in a given process. Second, chemical instability may make a compound attractive to use because its inherent reactivity ensures a reaction proceeds to completion at a rapid enough rate to be useful that is, the reaction is kinetically and thermodynamically favoured. 

As hydrogen sulfide is a neurotoxic agent, an inhalation study examining potential developmental neurotoxicity is needed. Such studies should include a battery of tests to examine the function of the nervous system in the offspring of animals exposed to hydrogen sulfide during gestation or for various periods before adulthood. 

The physicochemical and other properties of any newly identified drug must be extensively characterized prior to its entry into clinical trials. As the vast bulk of biopharmaceuticals are proteins, a summary overview of the approach taken to initial characterization of these biomolecules is presented. A prerequisite to such characterization is initial purification of the protein. Purification to homogeneity usually requires a combination of three or more high-resolution chromatographic steps (Chapter 6). The purification protocol is designed carefully, as it usually forms the basis of subsequent pilot- and process-scale purification systems. The purified product is then subjected to a battery of tests that aim to characterize it fully. Moreover, once these characteristics have been defined, they form the basis of many of the QC identity tests routinely performed on the product during its subsequent commercial manufacture. As these identity tests are discussed in detail in Chapter 7, only an abbreviated overview is presented here, in the form of Figure 4.5. 

Ishidate, M., Jr. (1988b). A proposed battery of tests for the initial evaluation of the mutagenic potential of medicinal and industrial chemicals. Mutation Res. 205 397-407. 

To summarize the utility of nonexperimental methods, it is obvious that the more available information there is about a compound, the more likely one will be able to substantially reduce the amount of testing involved in prediction of ocular irritation potential. However, at this point in time, none of the individual methods, alone or in combination, are sufficiently predictive to provide a definitive assessment of in vivo ocular irritation. There is definitely a place, however, for consideration of the above factors in a battery of tests, as well as for prioritizing compounds to be tested further. 

Thus, cytotoxicity assays are unlikely to provide an adequate predictor of in vivo irritation in every case. There is no doubt that some type of compounds (such as surfactants) will give (and have given) acceptable correlations with in vivo data. However, for the diversity of compounds common in the pharmaceutical industry, cytotoxicity assays alone are inadequate predictors of ocular irritation, though they may have a place in a battery of tests. For instance, if one is interested in a very quick assessment that will be corroborated later, cytotoxicity assays may be indicated. But each laboratory needs to make its own evaluation of the utility and value of these methods. 

Most clinical laboratories have established a standard battery of tests that includes most or all of the basic parameters listed in Table 20.12. If a dipstick is used to test the urine for several parameters, it is useful to use one that measures occult blood, even if a microscopic examination will count the number of red blood cells per high-power field. The means of obtaining the specimen should be indicated (i.e., normal voiding sample, clean catch, midstream, catheterization, suprapubic tap, or cytoscopy), especially in clinical trials in which an antidiuretic or antibiotic (or other relevant drug) is being tested. 

These studies are to determine if the drug compound can induce mutations to genes. A standard battery of tests includes the following ... 

Typically, ADME studies are included in the battery of tests used to characterize the toxicity of chemicals, as well as other studies designed to trace the underlying molecular and cellular events that lead to toxicity. These studies of toxic mechanisms take many forms, and are better viewed as research studies no general characterization of them will be made here, but some of the things such studies can reveal to aid understanding of risk will be mentioned at appropriate places in the remaining sections of the book. 

Evaluating a Child. Parents will often bring their children with the expectation that someone can test them for ADHD. It is true that certain tests can help in the initial assessment however, no single test or even battery of tests can alone make the diagnosis. Instead, this diagnosis is made only after collecting a thorough database of information from the child, his/her parents, and teachers. 

Dutka, B. Priority setting of hazards in waters and sediments hy proposed ranking scheme and battery of tests approach. German J. Appl. Zool. 1988, 75, 303-316. 

The core battery of studies should be carried out before a substance is administered to humans for the first time. Any follow up or supplementary safety pharmacology studies should be carried out if there is a cause for concern raised from the toxicological battery of tests and / or from studies in humans. 

A variety of cell-based and animal-based studies can be performed to ensure that a new chemical does not cause reproductive or developmental effects. A battery of tests is done to ensure that there are no harmful effects on fertility. Teratogenicity studies are performed to ensure that the chemical does not cause physical malformations in the offspring from exposure during pregnancy. Multiple generations of animals may be continuously exposed to ensure that a compound is safe. 

The current ICH harmonized tripartite guideline for genotoxicity testing of pharmaceuticals (S2B) defines a standard battery of tests, including both in vitro... 

In a study of age-associated memory impairment [Crook and Lakin 1991), using a double-blind, placebo-controlled trial and three doses of ondansetron (10, 250, or 1,000 pg po bid), patients were treated for 12 weeks, followed by a 2-week washout period, with assessments being made at the initiation of, during, and at the termination of treatment. Behavioral rating scales and a computerized battery of tests related to learning and memory tasks of daily life were used to assess changes in cognitive performance. Ondansetron caused dose-related effects to enhance acquisition, name-face associa-... 

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