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Common molecular biology techniques have never been carefully tested according to the basic principles of validation of quantitative techniques.
Our models have been developed in accordance with principles of validation adopted by OECD within the European Commission (EC) funded project CAESAR Computer Assisted Evaluationn of industrial chemical Substances According to Regulation) [30].
Only a brief, general description of the principles of validation of analytical methods will be given in this text; indeed, due to the complexity and variety of the involved procedures, instrumentation, etc., they will be the subject of a separate, dedicated guidance document.
This paper outlines the principles of validation and verification in the context of clinical human molecular genetic testing.
Although the number of samples was limited and far from satisfying the Principles of Validation of the OIE Terrestrial Manual [ 1], the pre-validation of the new rt-PCR assay presented here is a first important step in assessing its diagnostic capabilities.
This process not only contributed to the successful validation and international recognition of alternative methods for toxicological hazard identification tests but also established that the agreed principles of validation hold for any new and updated test method, whether it is an in vivo or in vitro method, and both for ecotoxicity tests as well as for human health tests.
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A useful guidance, edited under the umbrella of EANM Radiopharmacy Committee, for the use, installation, cleaning, and validation of automated systems has been recently published (Aerts et al. 2014), and general principles of cleaning validation may be found.
General Principles of Process Validation.
Written notes were used to focus follow-up sessions with the aim of improving coping strategies and empowering the participants to focus on the positive factors and resources in their lives, according to the principles of self validation.
Since a gold standard for measuring lifetime physical activity is not available to compare with the L-PAQ, the approach taken was to apply principles of construct validation, a process that usually involves a series of studies which strengthen the nomologic network of interlocking beliefs about the construct measured by the instrument (18).
Although these assays are tailored for the analysis of an antisense therapy targeting XIAP, it is hoped that the general principles of method validation presented may have broader applicability to other new agents requiring PD end point assays during early-phase clinical evaluation.
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