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The Organization of Preclinical and Premarketing Toxicity Testing

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The Future of Predictive Safety Evaluation
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Abstract

As indicated elsewhere in this book1, the first substantial official or quasi-official pronouncement on the conduct and interpretation of toxicity tests — of the kind relevant to safety evaluation — was made in 1955 by the staff of the US Food and Drug Administration2. With the thalidomide episode, legislation and codes of practice were introduced into or expanded by many countries, with in many instances the issue of guidelines for the type of testing regarded as necessary.

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References

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© 1987 MTP Press Limited

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Worden, A.N. (1987). The Organization of Preclinical and Premarketing Toxicity Testing. In: Worden, A.N., Parke, D.V., Marks, J. (eds) The Future of Predictive Safety Evaluation. Springer, Dordrecht. https://doi.org/10.1007/978-94-009-3201-2_2

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  • DOI: https://doi.org/10.1007/978-94-009-3201-2_2

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-7936-5

  • Online ISBN: 978-94-009-3201-2

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