July 08, 2016
The aim of this type of test is to determine the feasible dose of the test item for the start of the in vivo safety program.
The species to be used in the toxicity studies.
Dose escalation with single doses to detect acute toxicity effects of the test item.
After repeated administration of a selected dose, MTD is determined.
Preliminary toxicokinetic measurements can be included (see Pharmacokinetic support of pharmacological/toxicity studies).
Assessment of doses for repeated dose toxicity studies.
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