Spring Intro 2023

03/03/2023

The Nonclinical Overview

Toxicity - The appearance and duration of the toxic-effects, the dose-dependency and the reversibility or irreversibility. Species and/or sex related effects must be reviewed. Toxicokinetics. The evaluation should be arranged in a logical order so that all relevant data elucidating a certain effect/phenomenon are brought together.

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The Nonclinical Overview

Toxicity -

Extrapolation of data from species to species to humans should be discussed. The “most sensitive relevant” species should be identified (also needed by non-Toxicologists for “Safety Margins”)

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