Module 5 Presentations

16/07/2024

Typically, groups of animals at three dose/exposure levels are included in toxicology studies To characterise the potential adverse effects of the agent and so guide clinical regimens and safety monitoring. Repeat Dose Toxicology – Rodent & Non-rodent

Dose

Typical Target Exposure?

Purpose

An Ideal Outcome

Small multiple of human exposure

No Observed Effects (NOEL) No Observed Adverse Effect (NOAEL)

Low Dose

Mid Dose

Intermediate Exposure

What is the dose response for the potential hazards of the agent

Max Tolerated Dose (MTD) or Max Feasible Dose for animals. [High multiple of human exposure]

Moderate manifestations of Toxicity

High Dose

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

17

REPEAT DOSE TOXICOLOGY DURATIONS - ICH M3(R2) ICH M3 (R2) MARKETING IN ALL REGIONS

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

18

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