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Safety evaluation, of products

Onions D (1997), Safety evaluation of products derived from mammalian cell lines, In Flauser FI, Wagner R (Eds), Mammalian Cell Biotechnology in Protein Production, Walter de Gruyter, Berlin, pp. 171-190. [Pg.371]

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

It should be clear that a complete FMEA approach is not practical for the evaluation of production facility safety systems. This is because (1) the cost of failure is not as great as for nuclear power plants or rockets, for which this technology has proven useful (2) production facility design projects cannot support the engineering cost and lead time associated with such analysis (3) regulatory bodies are not staffed to be able to critically analyze the output of an FMEA for errors in subjective judgment and most importantly, (4) there are similarities to the design of all production facilities that have allowed industry to develop a modified FME.A approach that can satisfy all these objections. [Pg.398]

With a common intermediate from the Medicinal Chemistry synthesis now in hand in enantiomerically upgraded form, optimization of the conversion to the amine was addressed, with particular emphasis on safety evaluation of the azide displacement step (Scheme 9.7). Hence, alcohol 6 was reacted with methanesul-fonyl chloride in the presence of triethylamine to afford a 95% yield of the desired mesylate as an oil. Displacement of the mesylate using sodium azide in DMF afforded azide 7 in around 85% assay yield. However, a major by-product of the reaction was found to be alkene 17, formed from an elimination pathway with concomitant formation of the hazardous hydrazoic acid. To evaluate this potential safety hazard for process scale-up, online FTIR was used to monitor the presence of hydrazoic acid in the head-space, confirming that this was indeed formed during the reaction [7]. It was also observed that the amount of hydrazoic acid in the headspace could be completely suppressed by the addition of an organic base such as diisopropylethylamine to the reaction, with the use of inorganic bases such as... [Pg.247]

Noda T, Mortia S, Ohgaki S. 1984. A Safety Evaluation of Chemicals Used in Household Products (V) Teratological Studies in 2-Ethylhexyl Diphenyl Phosphate in Rats. Annu Rep. Osaka City Inst. Public Health Environmental Science 46 82-88. [Pg.347]

Brennan, F.R. and Dougan, G., Non-clinical safety evaluation of novel vaccines and adjuvants New products, new strategies, Vaccine, 23, 3210, 2005. [Pg.18]

U.S. Food and Drug Administration. Guidance for Industry. Nonclinical Safety Evaluation of Pediatric Drug Products. 2003. [Pg.361]

Shimizu M, Noda T, Yamano T, et al. 1992. Safety evaluation of chemicals for use in household products (XVII). A teratological study on hexachloroethane in rats. Osaka City Institute of Public Health and Environmental Sciences 54 70-75. (Japanese) [translation in progress]... [Pg.159]

Basic Principles for Preclinical Safety Evaluation of Cellular and Gene Therapies. For biotechnology-derived products in general... [Pg.66]

Quality of biotechnological products. Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin... [Pg.76]

TABLE 12.8. Issues in the Safety Evaluation of Species-Specific rDNA Products... [Pg.432]

Safety evaluation of a candidate product should start with a consideration of specific nature and consequential hazards of the three P s ... [Pg.433]

The safety evaluation of flavoring substances provides a unique challenge to regulators due to their large number and their generally low level of use. In addition, many flavoring substances occur in natural products (i.e., extracts, oleoresins, and essential oils) and have a long history of safe use. [Pg.209]

International Conference on Harmonization. Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Eluman or Animal Origin, CR, 1997. [Pg.358]

ICH (2009) Draft consensus guideline. Addendum to ICH S6 precUnical safety evaluation of biotechnology-derived pharmaceuticals, http //www.ich. org/fileadmin/Public Web Site/ICH Products / Guidelines/Safety/S6 ... [Pg.89]

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See also in sourсe #XX -- [ Pg.527 ]



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