Abstract
ICH has been successful to decrease inappropriate duplication of tests for candidates of pharmaceuticals. It contributed to provide harmonized guidelines respecting 3Rs principle proposed by Russel and Burtch (The principles of human experimental technique. Methuen, London, 1959). LD50 values for pharmaceuticals are not required anymore also in Japan. Circumstances where assessments of safety of metabolites are needed and that where repeated-dose tissue distribution studies are necessary were defined. All of these and other harmonization achieved through ICH contributed a lot to decrease the number of animal use and to promote welfare of animals in safety studies needed for pharmaceutical development.
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References
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© 2013 American Association of Pharmaceutical Scientists
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Ohno, Y. (2013). A Japanese Perspective on Implementation of the Three Rs: Incorporating Best Scientific Practices into Regulatory Process. In: van der Laan, J., DeGeorge, J. (eds) Global Approach in Safety Testing. AAPS Advances in the Pharmaceutical Sciences Series, vol 5. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-5950-7_4
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DOI: https://doi.org/10.1007/978-1-4614-5950-7_4
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