---
title: "Module 2.4: Non-clinical overview"
slug: "module-24-non-clinical-overview"
updated: 2025-05-01T19:40:25Z
published: 2025-05-01T19:40:25Z
canonical: "bgtcplaybook.document360.io/module-24-non-clinical-overview"
---

> ## Documentation Index
> Fetch the complete documentation index at: https://bgtcplaybook.document360.io/llms.txt
> Use this file to discover all available pages before exploring further.

# Module 2.4: Non-clinical overview

> [!NOTE]
> An Investigator Brochure containing a comprehensive summary of all non-clinical studies referenced in the IND may serve as a substitute for the **2.4 – Non-clinical Overview** and **2.6 – Non-clinical Written and Tabulated summaries**. Alternative approaches such as this may be considered on a case-by-case basis.

The overall goal of the non-clinical overview section is to provide the FDA with an integrated and critical assessment of the safety and efficacy of your product via **pharmacologic** and **toxicologic** evaluations. For more information on how to structure and key information to include in this section, check out the Module 2.4: Non-Clinical Overview template below and consider the pro-tips below while building yours. [[2]](/v1/docs/ref-ind-submission#module-2)

[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/NON-CLINICAL OVERVIEW_Template.docx)NON-CLINICAL OVERVIEW_Template30.60 KB[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/NON-CLINICAL OVERVIEW_Template.docx)

**Pro tip**: Ensure the document length is no more than **30 pages (maximum)**.

Some points you should consider highlighting in the non-clinical overview section include:

- Relevant guidances on the conduct of studies and provide justification for any deviation made from the guidances
- Discussion and justification of the non-clinical testing strategy
- Good laboratory practice (GLP) status of the studies being submitted
- Any association between non-clinical findings and the quality characteristics of the human pharmaceutical, clinical trials results, or effects seen with related analogues
- Any literature which contains data or methods used to support the non-clinical information of the drug
  - *You can cross-reference quality documents!*
  - *Can help justify proposed impurity in your drug substance and product*

As AAV gene therapies are biotechnology-derived products, it is highly suggested that you:

- Provide an **assessment** of the **comparability** of material you used in the non-clinical and clinical studies and one you are proposing to market
- Provide relevant scientific literature and the properties of related products
- For scientific literature used in place of studies conducted include justification around the design of the studies and deviations from available guidances
- Provide information on the quality of batches for drug substance used in these referenced studies
  - *If your drug product includes a novel excipient (i.e., an inactive substance that serves as the vehicle or medium for your AAV drug product, often to increase stability and thus shelf-life) then you should include excipient's safety information*