Module 5 Presentations

18/07/2024

IND Components (cont’d.)

Module 2 (Summaries), should include: ● IND introduction (Module 2.2) ● Quality Overall Summary (CMC) (Module 2.3) – This is generally a short introduction to the Drug Substance (DS) and Drug Product (DP) and references the reviewer to Module 3. ● Nonclinical: Provide any nonclinical summaries or overview as needed, may include: – Nonclinical overview (Module 2.4)

– Written and tabulated summaries to be included: – Pharmacology summary (Module 2.6.2/2.6.3) – Pharmacokinetics (PK) summaries (Module 2.6.4/2.6.5) – Toxicology summary (Module 2.6.6/2.6.7)

The Organisation for Professionals in Regulatory Affairs

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IND Components (cont’d.)

Module 2 (Summaries), should include (cont.) ● Clinical Overview and Summaries – Clinical Overview (Module 2.5) - contains data, rationale for pursuing indication – Since there is usually little clinical data when filing an IND, may only need to include Module 2.5. – Clinical Summary (Module 2.7) is also included when there is previous human experience. – Literature references. Module 3 (Quality) ● Full Chemistry, Manufacturing, Control (CMC) sections are required for an original IND ● Drug Substance (Module 3.2.S) ● Drug Product(s) (include active and placebo) (Module 3.2.P)

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