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In summary, the benefits of a mechanistic toxicology approach include increased understanding of the processes underlying primary pathology, the development of predictive capability, enhanced decision making and improved responsiveness to regulatory agencies. The overall objective of toxicology in the pharmaceutical industry is risk benefit assessment in order to support product registration. This requires both that studies be conducted in accordance with regulatory guidelines and that the biological processes underlying pathology be understood. These should be regarded as inseparable components of the risk assessment process.
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