Module 5 Presentations

16/07/2024

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

19

Study: Single dose, male Human Volunteers Aim: Safety and Pharmacokinetics

In vitro genetic toxicology

Bacterial mutations (‘Ames’) In vitro clastogenicity (mammalian cells) or “Option 2” General toxicology At least 2-weeks/2 species By clinical route (or maximise exposure) Up to maximum feasible/practical/tolerated doses Safety Pharmacology In vitro electrophysiology (eg: hERG for QTc effects) Effects on major body-systems Cardiovascular safety (conscious, telemetry) Supported by appropriate toxicokinetics

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

20

10