Subject testing protocols

There have been numerous communications on the subject of biodegradation test methods, including aerobic compost (30), anaerobic bioreactor (31), general methodology and future directions (32—34), and a fine review article (24). ASTM (22) and MITI (35) have also set forth standard testing protocols for plastics, as shown in Table 2, whereas OECD test methods (29) are more suited to water-soluble polymers. 

A sample of a standard calcium carbonate slurry was received from a large manufacturer in the USA. This sample was subjected to preservative efficacy testing according to the ASTM E 723-91 test protocol. Preservative treated samples were inoculated with a mixed bacterial inoculum containing organisms with a known tolerance or resistance to BIT (l,2-Benzisothiazolin-3-one). Untreated controls were included for reference purposes. The test procedure is outlined below. 

SUBJECT Process Simulation (Media Fill) Test Protocol... 

Test protocols should be used with information on the following subjects ... 

The concept behind the design of this testing protocol is that the plastic sample is delivered to a mammalian fibroblast culture. Once this exposure is made, the culture is evaluated for signs that the cells are interacting with the plastic or its leachants. Although some reaction is permissible, a subjectively defined upper limit is set beyond which the plastic or elastomeric container or closure will fail the test. The test protocol includes a positive control and a negative control in addition to the sample to assure that the system is valid. 

Enhanced Production Growth, as a primary metric of production, has been and is the subject of much research. Of substantial interest is the potential for use of transgenes in stimulating overproduction of growth hormones to enhance animal growth. Several test protocols have been evaluated with moderate success in various livestock models. 

Second, American physicians advocated a testing protocol and treatment method that required long hospitalization periods for intravenous administration. German patients, considered by physicians to be reliable participants and subject to observation and control outside the hospital, often received treatment on an ambulatory basis through subcutaneous application. These two... 

Once the intrinsic thermodynamic characteristics are firmly established, the storage materials will be subjected to the performance assessment test protocols. The performance parameters and conditions that will be derived from the testing regime are as follows. 

IRB oversight and approval, an FDA requirement, assures the safety of the human subjects employed in a test protocol. 

The attainment of these required characteristics is often not straightforward. Conformance with the requirements is usually obtained by a twofold process. First, substantial experience with the system and attention to important technical details is required. Second, certain statistical diagnostic tests may be used, the most impt>rtant being control charts, which arc defined in Section 7, using standard or reference materials subjected to the same testing protocol as the experimental materials. Independence of individual measurements can be compromised if there is any carryover effect or correlation between one test measurement (sample or specimen) and the next measurement. Calibration operations, to be discussed later, can also be a source of problems in test measurement independence if they arc not conducted in an organized or standardized manner. 

Not later than 30 months after October 28, 1992, the President shall, after notice and opportunity for comment, establish by rule appropriate criteria, testing protocols, and performance characteristics as are necessary to ensure, to the greatest extent possible and consistent with the purposes and policy of this subchapter, that lead-based paint hazard evaluation and reduction products introduced into commerce after a period specified in the rule are effective for the intended use described by the manufacturer. The rule shall identify the types or classes of products that are subject to such rule. The President, in implementation of the rule, shall, to the maximum extent possible, utilize independent testing laboratories, as appropriate, and consult with such entities and others in developing the rules. The President may delegate the authorities under this subsection to the Environmental Protection Agency or the Secretary of Commerce or such other appropriate agency. 

The Bitrex (Denatonium benzoate) solution aerosol QLFT protocol uses the published saccharin test protocol because that protocol is widely accepted. Bitrex is routinely used as a taste aversion agent in household liquids which children should not be drinking and is endorsed by the American Medical Association, the National Safety Council, and the American Association of Poison Control Centers. The entire screening and testing procedure shall be explained to the test subject prior to the conduct of the screening test. 

All four of these activities are important, and the first two are especially so because the quality of the results is entirely dependent on having quahfied subjects, a language, and a testing protocol. 

Although it is commonly expected that nanoporous polymer foams will present improved properties over conventional or microporous foams, there are just a few experimental evidences about this behavior. The main limitation to characterize several properties of nanoporous foams is the production of sufficiently large samples that can be subjected to standard test protocols (with most of the results reported previously obtained in the form of thin films). 

Although there appears to be considerable standardisation of test protocols for the predictive identification of skin sensitisers (Organisation for Economic Cooperation and Development 1993), both the use and the interpretation of test data is subject to wide variations (Robinson et al. 1990 Frankild et al. 1996). It is almost impossible to overestimate the variability of the results which can be obtained by different laboratories testing the same substance and using the same protocol. 

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