Regulatory Toxicology: Essentially Practical Aspects

REGULATORY TOXICOLOGY is designed to be very useful & appropriate in conducting tests for development & registration of chemical products in different countries, before the consumers are exposed to these chemicals. It has comprehensive and practical information about the procedures involved in generating toxicology data which have to be submitted to regulatory authorities. It describes methods for carrying out acute, sub-acute & long term studies, besides mutagenicity, carcinogenicity neurotoxicity & reproduction studies. Details of necroscopic, clinical biochemistry & haematology, histology methods are given. Experimental procedures of all major studies are explained. Statistical tools used for analyzing toxicology data are described in the chapter on statistical methods used for regulatory toxicology. The tools include the utility of randomisation, one & two tailed tests & quantitative analysis for analyzing dose- relationship. Managerial aspects of Good Laboratory Practices (GLP) are focused, especially planning, administration and decision making, in terms of facility, resources, equipment, personnel and procedures (for recording of data governed by regulations) including preparing for inspection by external agencies as well as on GLP policies. There is a chapter that outlines the possibilities of utilizing animal alternatives in order to practice the 3R's (Replacement, Reduction, Refinement) in regulatory toxicological Studies.