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Safety evaluation

Toxicology of degradation products Antigenicity Oncogenic Studies [Pg.262]


The preclinical trials are performed in in vitro and animal studies to assess the biological activity of the new compound. In phase 1 of the clinical trials the safety of a new drug is examined and the dosage is determined by administering the compound to about 20 to 100 healthy volunteers. The focus in phase II is directed onto the issues of safety, evaluation of efficacy, and investigation of side effects in 100 to 300 patient volimteers. More than 1000 patient volunteers are treated with the new drug in phase 111 to prove its efficacy and safety over long-term use. [Pg.602]

Vital Safety Evaluation of Biotechnology Products Derived from CeU Liaes of Human or Animal Origin," ICH Harmonized Tripartite Guideline,... [Pg.145]

Council for Agricultural Science and Technology, (CAST) ELormonallj Active Substances in Foods A Safety Evaluation, Task Force Report No. 66,... [Pg.36]

J. M. Smith and co-workers, "Methyl Methacrylate Subchronic, Chronic and Oncogenic Inhalation Safety Evaluation Studies," Mbstracts of the Eighteenth Mnnual Meeting of the Society of Toxicology, New Orleans, La., 1979. [Pg.257]

Safety Evaluation of the Midwest Fuel Recovey Plant, General Electric Co., Docket No. 50-268, United States Atomic Energy Commission, Washington,... [Pg.208]

Drake, E. M. and C. W. Thurston. 1992. A Safety Evaluation Eramework for Process Hazards Management in Chemical Eacilities with PES-Based Controls. Process Safety Management Paper 73d. AlChL 1992 Summer National Meeting, August 1992, Minneapolis, MN. [Pg.148]

When the review progresses to the point that the staff concludes that the documentation is acceptable, a Safety Evaluation Report is prepared that represents a summary of the review and evaluation of the application by the staff. [Pg.19]

King, F. K. et al., 1987 The Darlington Probabiiisitic Safety Evaluation - A CANDU Risk Assessment, Canadian Nuclear Society 8th Annual Conference, Proceedings, pp 15 i -178. [Pg.483]

Ontario Hydro, 1987, Darlington Probabilistic Safety Evaluation. ... [Pg.486]

TABLE 5.24 Toxicity Studies for Safety Evaluation of Drugs, Pesticides, Food Additives, and Other Chemicais Utilizing Experimental Animals and Other Systems Required by Health Authorities... [Pg.329]

Miller, M. J. Risk Management and Reliability—An Update. Paper presented at the Conference on Fire Safety Evaluation, National Academy of Sciences, Washington, D.C., September 1978. [Pg.237]

Fauske, H. K., M. A. Grolmes, and G. LI. Glare, Process Safety Evaluation Appl) ing DIERS Mediodolog) to Existing Plant Operations, Plant Operations Progress, Vol. 8, No. 1, 1989, p. 40. [Pg.542]

Fauske, H. K., Grolmes, M. A. and Clare, G. H., Process Safety Evaluation—Applying DIERS Methodology To Existing Plant Operations, Paper presented at the 1988 Spring National Meeting of the AIChE, New Orleans, LA, March 6-10, 1988. [Pg.546]

A small amount of hydrazine hydrate was present in the reaction mixture at this point, but a safety evaluation indicated the final reaction mixture had a very low thermal potential (AH = 15.3 J/g). This poses a minimum thermal hazard for vacuum distillation. [Pg.133]

More recent publications on sulfosuccinates have confirmed the minimal or close to zero skin and eye irritation caused by these products. In a general screening of product safety evaluation methods the authors [16] rejected the sulfosuccinate from further consideration in the statistical analysis of experimental data (variance analysis) because the product had not shown any irritation in the Duhring-Chamber test. The sulfosuccinate (based on fatty alcohol ethoxy late) was tested in a screening with 14 other surfactants, namely, alkyl sulfates, sulfonates, ether sulfates, and a protein fatty acid condensation product. [Pg.505]

S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals... [Pg.60]

Hess R, Schweinfurt H (1989) Safety evaluation of octyltin stabilizers. Ciba-Geigy Ltd/Schering AG, 8 August. [Pg.46]

Isshiki K, Miyata K, Martsui S, et al. 1983. [Effects of post-harvest fungicides and piperonyl butoxide on the acute toxicity of pesticides in mice. Safety evaluation for intake of food additives. III]. [Pg.214]

Peroxidation of lipids is another factor which must be considered in the safety evaluation of liposome administration. Smith and coworkers (1983) demonstrated that lipid peroxides can play an important role in liver toxicity. Allen et al. (1984) showed that liposomes protected by an antioxidant caused less MPS impairment than liposomes subjected to mild oxidizing conditions. From the study of Kunimoto et al. (1981) it can be concluded that the level of peroxidation in freshly prepared liposome preparations and those on storage strongly depends both on the phospholipid fatty acid composition and on the head group of the phospholipid. Addition of appropriate antioxidants to liposomes composed of lipids which are liable to peroxidation and designed for use in human studies is therefore necessary. [Pg.311]

Parke DV, loannides C, Lewis DFV. The safety evaluation of drugs and chemicals by the use of computer-optimised molecular parametric analysis of chemical toxicity (COMPACT). ATLA 1990 18 91-102. [Pg.493]

Lewis DFV, loannides C, Parke DV. Validation of a novel molecular-orbital approach (COMPACT) for the prospective safety evaluation of chemicals, by comparison with rodent carcinogenicity and Salmonella mutagenicity data evaluated by the United States NCI NTP. Mut Res 1993 291 61-77. [Pg.493]

The intensely sweet sesquiterpene hernandulcin isolation, synthesis, characterization and preliminary safety evaluation. J. Agric. Food Chem. 35 273-279. [Pg.308]

World Health Organization, Series, 52, Safety evaluation of certain food additive and contaminants. International Programme on Chemical Safety, Geneva, 55, 2004. Tylak, K.C. et ah. Antioxidant availability of turmeric in relation to its medicinal and culinary uses, Phytoter. Res., 18, 798, 2004. [Pg.344]

Mokady, S., Abramovici, A., and Cogan, U., The safety evaluation of Dunaliella bardawil as a potential food supplement. Food Chem. Toxicol, 27, 221, 1989. [Pg.423]

Chemical contaminants are usually not reduced or removed by processing steps. Chemical risks must preferably be controlled as early as possible in the agri-food chain. Food color additives (Section 7.1.3) are chemical compounds and are considered potential risks. Therefore a safety evaluation is part of the approval of a food colorant before its use is acknowledged by legislation (see also Section 7.1.6). This section explains the principles of risk assessment and includes an example of such an assessment of a specific food colorant. [Pg.566]


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