Module 5 Presentations

16/07/2024

Metabolites: FDA Guidance for Industry (March 2020)

“Disproportionate”: Human >>> Animals

https://www.fda.gov/media/72279/download

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

35

THE TEST MATERIAL

All medicines contain more than the active drug !

ACTIVE DRUG

• • • • • • •

Related substances Process residues Degradation products

Quality: ICH Q3A, B and C Guidelines

Excipients

Other active materials

‘Extractives’

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

36

18