Spring Intro 2023

22/03/2023

“ All substances are poisons; there is none that is not a poison. The right dose differentiates a poison and a remedy”

Paracelsus, 1493-1591

A Safe Medicine ” is a relative term. It does NOT mean “ risk free ”

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Summary

1. Why are safety studies (toxicity tests) done? ● to give best possible assurance a new medicine won’t cause serious or irreversible harm to humans 2. What toxicity tests are needed? ● depends on type of product, intended purpose, conditions of use and results of earlier tox studies 3. When should tests be done? ● Before, during, or occasionally after clinical development 4. “Regulatory Guidelines” are NOT = Requirement Don ’ t assume studies are necessarily human (ir)relevant. Check clinical links for safety Avoid! Standardisation & dogmatism 5. Clinical studies do NOT usually detect 3 types of toxicity: ● (i) genetic toxicity ● (ii) cancer risks ● (iii) reproductive toxicity

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