Module 5 Presentations

05/07/2024

Non-clinical Module

• Tabulated summaries of non-clinical studies with brief narratives • Tables should be sufficient to demonstrate suitability of study to support CT • Studies to be structured logically (as CTD) – Refer to NtA • Guidance on non-clinical safety studies in ICH M3 – Justify guideline deviations • Studies should comply with GLP, non-GLP studies should be justified • Test material must be representative of IMP or further justification provided

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Non-clinical Module Headings

Overview of Non-clinical testing Pharmacology Pharmacokinetics Toxicology Overview and Conclusions List of References

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