- Minimum lethal dose of a test substance
- Dose range for CNS responses
- Primary effects on behavior and physiological functions
Irwin test results are used to predict potential therapeutic activity and to select doses for subsequent efficacy tests. In addition, these data are also used to assess the risks associated with the use of a drug candidate in safety pharmacology studies.
Irwin Test Procedure
Rats or mice are administered the test substance and then observed for the next several hours and on the following day. Clinical signs are grouped into several categories in an attempt to highlight the particular characteristics of the test substance, as follows:
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Safety pharmacology satisfies a key requirement in the drug development process, assessing any potential adverse effects that drug candidates may have on the body’s major physiological systems
PK/PD and Metabolism
During the drug discovery process, ADME (absorption, distribution, metabolism, and excretion) and PK studies are deemed necessary to evaluate bioavailability.