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The Pre-marketing Establishment of the Side-effect Profile of a New Drug

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The Detection of New Adverse Drug Reactions

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Abstract

Before embarking on drug studies in humans there must be adequate toxicological testing in animals. The extent of this preclinical toxicological screening was outlined in 1982 by Professor D.G. Grahame-Smith249 and this is also dealt with in ‘Safety requirements for the first use of new drugs and diagnostic agents in man’. The latter also covers Phase 1250.

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Authors
  1. M. D. B. Stephens
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© 1988 M.D.B. Stephens

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Stephens, M.D.B. (1988). The Pre-marketing Establishment of the Side-effect Profile of a New Drug. In: The Detection of New Adverse Drug Reactions. Palgrave, London. https://doi.org/10.1007/978-1-349-09887-3_5

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