The significance of excursions above the ADI: duration in relation to pivotal studies.

  • Ron H Walker
  • Published 1999 in Regulatory toxicology and pharmacology : RTP


The significance of excursions of intake above the ADI, TDI, or PTWI can only be assessed by reference to the database which led to the derivation of these, most particularly the duration of the pivotal study (chronic, subchronic, acute), the pharmacokinetic parameters, and the nature of toxicity and mechanism of action. Although this implies a case by case… (More)


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