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Standard tests are often performed according to GLP, whereas non-standard tests are seldom performed according to GLP.
Non-standard tests, on the other hand, are tests performed according to any other test method.
Overall the evaluation of the nine selected non-standard tests resulted in a low number of studies with acceptable reliability.
To enable the use of non-standard tests in risk assessments, two things are needed: that the legislation is designed so that non-standard tests can be included in a systematic and predictable way, and that non-standard tests are reported in a transparent and comprehensive way, much like required when using the standard test methods.
Ethinylestradiol can therefore be seen as an example where non-standard tests with more substance-specific endpoints are more sensitive compared to the standard tests.
A direct comparison is made between the results from the proposed non-standard tests on core samples and the tests suggested by the available standards on prismatic samples.
The experimental results from standard and non-standard tests were properly investigated in order to obtain the shear failure envelope of the bond interface and mortar joint.
However, in practice, it is possible that non-standard tests fulfill all criteria, except the one regarding GLP, regardless of whether the test is closely related to a standard test or not.
For this reason, non-standard tests, or tests following modified test guidelines, can provide valuable information and should not per se be considered less reliable for dose response assessment purposes.
Standard test data are still preferred and recommended for regulatory environmental risk assessments of pharmaceuticals even though data generated by non-standard tests could improve the scientific basis of risk assessments by providing relevant and more sensitive endpoints.
As we see it, there are at least three ways forward: (1) to develop new standard ecotoxicity tests better suited for pharmaceuticals, or (2) to adjust existing standard tests by supplementing them with additional endpoints relevant for different pharmacological modes-of-action, or (3) to increase the use of non-standard tests for risk assessment purposes.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com