📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. The Nonclinical Data Reviewer's Guide (nSDRG) for the SEND datasets — the animal-study equivalent of the clinical reviewer's guides.
Why it exists. The FDA requires nonclinical study data in the CDISC SEND standard. The nSDRG explains the datasets, any conformance notes, and how to navigate them — so a reviewer can re-examine the animal data, not just read the reports.
How it is produced here. It is generated from the standardized study datasets (the SDTM and ADaM data and their define.xml 'data dictionary'), so the guide always describes the exact datasets a regulator would receive.
Format & governing standard. CDISC SEND IG 3.1 · ICH M4 · FDA Study Data Technical Conformance Guide
| Field | Value |
|---|---|
| Document ID | SEND-001 |
| Version | 1.0 |
| Compound | GLPI-103 (GLP-1/APJ dual agonist) |
| Standard | CDISC SEND IG 3.1 · ICH M4 · FDA Study Data Technical Conformance Guide |
| Confidentiality | Confidential — portfolio use |
[MOCK — deep-knowledge assumption]No nonclinical raw data are simulated; this nSDRG documents the of the SEND datasets that would accompany the pivotal nonclinical studies (M4-2.3), per the FDA study-data standards expectations for NDA submissions.
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| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-30 | Nonclinical / Data Standards | Initial nSDRG |
This guide assists reviewers in navigating the SEND-formatted nonclinical datasets submitted in Module 4. SEND datasets are provided for the pivotal GLP toxicology studies that support the marketing application; non-pivotal and exploratory studies are submitted as reports only, consistent with the FDA Technical Conformance Guide.
| Study | Type | Species | SEND |
|---|---|---|---|
| 13-week repeat-dose toxicity | GLP general tox | Rat | Yes |
| 13-week repeat-dose toxicity | GLP general tox | Non-human primate | Yes |
| 26-week repeat-dose toxicity | GLP general tox | Rat | Yes |
| 39-week repeat-dose toxicity | GLP general tox | Non-human primate | Yes |
| 2-year carcinogenicity | GLP carcinogenicity | Rat | Yes |
| Embryo-fetal development | GLP DART | Rat / rabbit | Yes |
[MOCK]Each SEND study maps to its study report in M4-2.3 (toxicology) and is referenced from the Nonclinical Overview (M2.4) and the Nonclinical Written/Tabulated Summaries (M2.6).