Proposed guidelines

To ensure that computational chemistry develops in an orderly way, researchers must provide certain information so that others can reproduce and analyze their results. Gund et al. proposed guidelines for reporting molecular modeling results. You should consider these guidelines for your publications. 

For a detailed discussion of the art of sample handling and data acquisition for blood gas measurements, see National Committee for Clinical Laboratory Standards. Blood gas pre-analytical considerations specimen collection, calibration, and controls Proposed Guideline. NCCLS publication C27-P, Villanova, Pennsylvania, NCCLS, 1985... 

NCCLS (1995) The reference system for the clinical laboratory criteria for development and cre-dentialing of methods and materials for harmonization of results proposed guideline. Wayne, Peimsylvania. NCCLS document NRSCL I3p. 

The US-EPA has in its 1996 Proposed Guidelines for Carcinogen Risk Assessment (US-EPA 1996) adopted the dose descriptor LEDio (the 95% lower confidence limit on a dose associated with a 10% extra tumor risk) whereas in its 2005 Guidelines for Carcinogen Risk Assessment (US-EPA 2005), no defined incidence has been recommended (see Section 6.3.2). Within the EU chemical s regulation, the dose descriptor T25 has been proposed (see Section 6.3.3). In the newly proposed MOE approach, the JECFA and the EFSA have recommended the dose descriptor BMDLio (see Section 6.4). 

In 1996, the US-EPA published their Proposed Guidelines for Carcinogen Risk Assessment (US-EPA 1996). These Proposed Guidelines were a revision of the 1986 Guidelines for Carcinogen Risk Assessment (US-EPA 1986) and introduced, among others, a new approach for the quantitative risk assessment. A revised draft Guidelines was launched in 1999 (US-EPA 1999) and the final version was published in 2005 (US-EPA 2005). 

US-EPA. 1996. Proposed Guidelines for Carcinogen Risk Assessment (April 23, 1996). Eederal Register 61(79) 17960-18011. Washington, DC Office of Research and Development. U.S. Environmental Protection Agency. http /www.epa.gov/ncea/raf/pdfs/propcra 1996.pdf... 

Consistent with the read-analyze-write approach to writing used throughout this textbook, this chapter begins with an excerpt from a research proposal for you to read and analyze. Excerpt 11A is taken from a proposal that competed successfully for a graduate fellowship offered by the Division of Analytical Chemistry of the American Chemical Society (ACS). As is true for nearly all successful proposals, the principal investigator (PI) wrote this proposal in response to a set of instructions. We have included the instructions with the excerpt so that you can see for yourself how closely she followed the proposal guidelines. 

If proposal guidelines do not specify a citation/reference format, use a format common in your field. Numerical formats are preferred because they save space. 

For research proposals, expectations are specified in Requests for Proposals (RFPs) and supplementary grant proposal guidelines. 

Because of the risk of compromise of cardiac status, it is currently recommended that baseline HR, BP readings, and EKGs be obtained from all potential TCA patients. Both Wilens et al. (1996) and the American Heart Association (Gutgessel et ah, 1999) have proposed guidelines for EKGs based on age-normal values and clinical experience. These are summarized in table 23.4. 

Over the past few years, many guidelines have been developed to address (1) drug quality, (2) efficacy, (3) safety, and (4) regulatory communication. The ICH has developed more than 170 proposed guidelines 64 of them have been adopted by the regulatory agencies in the United States, European Union, and Japan. 

International Pharmaceutical Excipients Council (IPEC). The proposed guidelines for the safety evaluation of new excipients, The IPEC Europe Safety Committee. Eur Pharm Rev 1997. 

One conclusion in the proposed guidelines is that it is the sponsor s responsibility to identify comprehensively the microbiological activity of their product, to determine the appropriate microbiological end-points to be measured, and to establish the antimicrobial NOEL in an appropriate model system. These new guidelines may have a significant impact on future registration of antimicrobial animal drug products. 

Food and Drug Administration, in Proposed Guideline. Microbiological Testing of Antimicrobial Drug Residues in Food, Food and Drug Administration, Rockville, MD (1993). 

Finally, WHO stated that the judgment about safety, or what is an acceptable risk level, is a matter in which society as a whole has a role to play. The final judgment as to whether the benefit of adopting any of the proposed guidelines does or does not justify the risk is for each country to decide. 

Any analytical method should be validated. The U.S. Food and Drug Administration has proposed guidelines on submitting samples and analytical data for validation (78). In LC one should check at least specificity, selectivity, accuracy, precision, linearity, reproducibility, limit of detection, limit of quantitation, and robustness. 

The U.S. Food and Drug Administration (FDA) has proposed guidelines with the following definition for process validation [1] ... 

Validation is an essential procedure that demonstrates that a manufacturing process operating under defined standard conditions is capable of consistently producing a product that meets the established product specifications. In its proposed guidelines, the U.S. Food and Drug Administration (FDA) has offered the following definition for process validation [1],... 

EPA. Proposed Guidelines for Carcinogen Risk Assessment. Fed. Reg. 61 17960-18011, 1996. EPA. Guidelines for Carcinogen Risk Assessment. Risk Assessment Forum, US Environmental Protection Agency, NCEA-F-0644, July 1999, Review Draft. 

US Environmental Protection Agency. Proposed guidelines for ecological risk assessment. Washington, DC Risk Assessment Forum, USEPA, 1996. EPA/630/R-95/002B. 

EPA (1996a). U.S. Environmental Protection Agency. Proposed guidelines for carcinogen risk assessment, 61 FR 17960 (U.S. Government Printing Office, Washington). 

USEPA (1996). Office of Research and Development. Proposed Guidelines for Carcinogen Risk Assessment. Washington, DC EPA/600/P-92/003C. April. 

Historically, the impact of diet on health has been a concern of man. In recent years we have seen greater emphasis on how nutrition relates to health and the prevention of chronic afflictions such as coronary heart disease, hypertension, obesity, and cancer. Consequently, several health organizations have proposed guidelines to promote better health and reduce risk... 

With the great diversity of chemicals and the various modes of action, it is very likely that scaling (extrapolating) equations like Equation 1 will differ for different chemicals. Thus, decisions on how genetic-risk estimates are to be extrapolated to man will have to be made in different ways for different chemicals. This point of view is reflected, at least implicitly, in the recently published EPA proposed guidelines for mutagenicity risk assessments.4... 

We do not intend to imply that this is the only possible decision function. For example, a chemical may already have undergone several tests not included in this system. In such circumstances, a weight-of-evidence approach is appropriate, as described in the EPA proposed guidelines for mutagenicity risk assessment.1+75... 

U.S. Environmental Protection Agency proposed guidelines for registering pesticides in U.S.A. Hazard evaluation Humans and Domestic Animals, FIFRA ACT, Fed, Reg., 43 37335, August 22, 1978. 

Bush TM, Shlotzhauer TL, Imai K (1991) Nonsteroidal anti-inflammatory drugs proposed guidelines for monitoring toxicity. West] Med 155 39-42. 

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