Test validity

Klein, H. H., Analyses of DIERS Venting Tests Validation of a Tool for Sizing Emergency Relief Systems for Runatvay Chemical Reactions," Plant/Operations Progress, 5 (1), 1-10, January 1986. 

At sufficiently low strain, most polymer materials exhibit a linear viscoelastic response and, once the appropriate strain amplitude has been determined through a preliminary strain sweep test, valid frequency sweep tests can be performed. Filled mbber compounds however hardly exhibit a linear viscoelastic response when submitted to harmonic strains and the current practice consists in testing such materials at the lowest permitted strain for satisfactory reproducibility an approach that obviously provides apparent material properties, at best. From a fundamental point of view, for instance in terms of material sciences, such measurements have a limited meaning because theoretical relationships that relate material structure to properties have so far been established only in the linear viscoelastic domain. Nevertheless, experience proves that apparent test results can be well reproducible and related to a number of other viscoelastic effects, including certain processing phenomena. 

Established in 1894, AOAC International is an independent association of scientists and organizations in the public and private sectors devoted to promoting methods validation and quality measurements in the analytical sciences. AOAC has a mission to ensure the development, testing, validation, and publication of reliable chemical and biological methods of analysis for foods, drugs, feed-stuffs, fertilizers, pesticides, water, forensic materials and other substances affecting public health and safety and the environment. 

Figure 1. The process of model testing/validation. (Reproduced with permission from Ref. 2.)...

Amacher, D.E., S C Pail lei. G.N.Tumer, V.A.Ray, and D.S.Salsburg. 1980. Point mutations at the thymidine kinase locus in L5178Y mouse lymphoma cells. II. Test validation and interpretation. Mutat. Res. 72 447-474. 

Traditionally, the education that chemists and chemistry laboratory technicians receive in colleges and universities does not prepare them adequately for some important aspects of the real world of work in their chosen field. Today s industrial laboratory analyst is deeply involved with such job issues as quality control, quality assurance, ISO 9000, standard operating procedures, calibration, standard reference materials, statistical control, control charts, proficiency testing, validation, system suitability, chain of custody, good laboratory practices, protocol, and audits. Yet, most of these terms are foreign to the college graduate and the new employee. 

C O LI P A international in vitro phototoxicity test validation study and the ECVAM/... 

Hartung T, Bremer S, Casati S et al (2004) A modular approach to the ECVAM principles on test validity. Altern Lab Anim 32(5) 467- 72... 

Key words In vitro. Alternative tests. Validation, Developmental, Reproductive, Toxicology... 

ECVAM is the leading international center for alternative test method validation. Hartung et al. (29) summarized the modular steps necessary to accomplish stage 3 (test validation). The seven modular steps are (I) test definition, (2) within-laboratory variability, (3) transferability, (4) between-laboratory variability, (5) predictive capacity, (6) applicability domain, and (7) performance standards (29). Steps 2-4 evaluate the test s reliability steps 5 and 6 evaluate the relevance of the test. Successful completion of all seven steps is necessary to proceed to stage 4 (independent assessment or peer review). This modular approach allows flexibility for the validation process where information on the test method can be gathered either prospectively or retrospectively. The approach is applicable not only to in vitro test methods but also to in silico approaches (e.g., computer-based approaches such as quantitative structure-activity relationships or QSAR) and pattern-based systems (e.g., genomics and proteomics). 

Figure 4. Burning rate data plotted to test validity of granular diffusion flame theory (99)...

Sterility test validations are performed per current USP Section <71>. The validation is performed on a single lot of the largest volume, highest product strength to simulate the maximum concentration of active drug substance on the membrane hlter. 

Sterility test validation per manufacturer validation protocol... 

An applicant can submit one or more protocols (i.e., comparability protocols) describing tests, validation studies, and acceptable limits to be achieved to demonstrate the absence of an adverse effect from specified types of changes. A comparability protocol can be used to reduce the reporting category for specified changes. A proposed comparability protocol should be submitted as a prior approval supplement, if not approved as part of the original application. FDA intends to issue separate guidance on comparability protocols. 

Cleaning validation protocols should describe the equipment to be cleaned, procedures, materials, acceptance criteria, parameters to be monitored and controlled, and the analytical methods to be employed for testing. Validation of cleaning procedures should reflect equipment to be used for key and final intermediates and APIs. The selection of cleaning procedures to be employed should be based on material solubility and cleaning difficulty. The calculation of residue limits should consider the potency, toxicity, and stability of critical materials. 

Validation Testing. Validation testing is the exercise of the verified applications software in a certified... 

Hansen, V., Clausen, P.A. and Wolkoff, P. (2001) Quality control measures for FLEC emission testing-validation af analytical method. Proceedings of Second International FLEC Symposium, pp. 116-20. 

In connection with the SHEBA project, the U.S. Department of Energy s Atmosphere Radiation Measurement (ARM) program indicated its intention to develop a Cloud and Radiation Testbed (CART) facility on the North Slope of Alaska. The principal focus of this program will be on atmospheric radiative transport, especially as modified by clouds (such transport impacts the growth and decay of sea ice), as well as testing, validation, and comparison of radiation transfer models in both the ice pack and Arctic coastal environment. 

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