Evaluation Guidelines

Moriasi DN, Arnold JG, Van Liew MW, Bingner RL, Harmel RD, Veith TL (2007) Model evaluation guidelines for systematic quantification of accuracy in watershed simulations. Trans ASABE 50(3) 885-900... 

One of IPEC s greatest accomplishments has been the development of new excipient safety evaluation guidelines. Previously, there were no generally accepted safety evaluation processes for excipients anywhere in the world. The IPEC guidelines fill this void. 

There are many misconceptions associated with the CLP analysis. For example, many environmental professionals believe that because of the prescriptive protocols and unambiguous data evaluation guidelines, the CLP methods produce better quality data than their SW-846 equivalents. In fact, some of the CLP methods may be less accurate than their SW-846 counterparts. For example, the calibration requirements of the CLP SOW for Organic Analysis (EPA, 1999d), are not as stringent as these of the equivalent SW-846 methods. In addition, matrix effects have an equal impact on data quality independent of the analytical method used. The CLP produces better quality data only in terms of better consistency between laboratories, more thorough documentation, and uniform QC acceptance criteria. 

McGuire WL. Breast cancer prognostic factors evaluation guidelines. J. Natl. Cancer Inst. 1991 83 154-155. 

Through this evaluation, guidelines are being proposed to establish criteria for an adequate test in each of the major assays. 

Basic information on facilities investment, coal, utilities, and operating labor for the 100 million SCF/day base case was obtained from Reference (JO and adjusted to a mid-1979 basis. Based upon the economic evaluation guidelines for 100 million SCF/day hydrogen production with Wyoming coal at 20/ton ( 1.17/106 Btu), the total capital required is 298.8 X 106 and the hydrogen price is 3.66/103 SCF, or 11.20/106 Btu. For Illinois coal at 20/ton, total capital required is 270.1 X 106 and hydrogen price is 3.19/103 SCF, or 9.76/106 Btu. 

In the present study example the feasibility of the development of a slow-release formulation was evaluated. Guidelines on the design and conduct of such studies have not yet been published. 

Progress in drug delivery systems and new proteins/ peptides being developed for parenteral administration has created a need to expand the list of excipients that can be safely used. An informational chapter included in the USP 24, presents a scientifically based approach for safety assessment of new pharmaceutical excipi-ents.f This chapter is based on the excipient safety evaluation guidelines prepared by The Safety Committee of the International Pharmaceutical Excipient Council, with appropriate reaction. Table 14 summarizes the approach in developing a new excipient. 

USP (1074) excipient biological safety evaluation guidelines. In United States Pharmacopeia, 24th Ed. US Pharmacopeial Convention Inc. Rockville, 2000 2037. 

A set of evaluation guidelines was established and was applied to several model experiments. 

Excipient Biological Safety Evaluation Guidelines, General Chapter <1074>, and Excipients USP and NF Excipients, Listed by Categories, pp. 2404-2406, in USP 24-NF 19. U.S. Pharmacopeil Convention, Rockville, MD, 2000. 

Jackson, L. E., J. C. Kurtz, and W. S. Eisher (eds.) 2000. Evaluation Guidelines for Ecological Indicators. EPA/620/R-99/005. U.S. Environmental Protection Agency, Office of Research and Development, Research Triangle Park, NC. 107 pp. 

Goldenthal, E. I. (Chief, Drug Review Branch - Division of Toxicological Evaluation, Bureau of Scientific Standards and Evaluation) Guidelines for Reproduction Studies for Safety Evaluation of Drugs for Human Use, letter dated March 1,... 

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