Module 5 Presentations

16/07/2024

Up to 14-days Clinical Study into Therapeutic range

“Approach 4: A 2x14-Day toxicology”

NB: Abridged version of full guideline recommendations

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

23

Up to 14-days Clinical Study into Therapeutic range

“Approach 5: A 2-Week rodent and confirmatory non-rodent”

NB: Abridged version of full guideline recommendations

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

24

12