Spring Intro 2023

22/03/2023

TOPRA Introductory Course 2023

Understanding the Need for

Non-Clinical Safety (Toxicity) Studies

A presentation by Dr Chris J Powell FRCPath

 Why are preclinical safety assessment & toxicity studies used in medicines Research & Development?  Safety studies to enable “first in human” trials  Guidance: General & Reproductive toxicity, Carcinogenicity tests  Safety Tests for Advanced Therapy Products  Interpreting study results? New Regulatory developments.

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

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What is Toxicity ?

● Any unwanted effect on normal structural or functional integrity. It includes, unwanted pharmacological effects , as well as more conventional tissue damage, which is commonly mediated by metabolism ● Side effect, over-exaggerated pharmacology, adverse drug reaction, common in over-dose situations.

BAD , Damage ,

Harm , DEATH

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