📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.

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Mock / simulation document

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.

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About this document — a plain-language guide

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

Nonclinical Data Reviewer's Guide (nSDRG) — SEND — GLPI-103

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 structure, scope, and known conformance considerations of the SEND datasets that would accompany the pivotal nonclinical studies (M4-2.3), per the FDA study-data standards expectations for NDA submissions.

Change History

Version	Date	Author	Summary
1.0	2026-06-30	Nonclinical / Data Standards	Initial nSDRG

1. Purpose and Scope

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.

2. Studies Submitted in SEND

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

3. SEND Domains Included

Trial design: TS (trial summary), TX (trial sets), TA/TE (arms/elements), TI (inclusion/exclusion).
Special-purpose/findings: DM (demographics), EX (exposure), DS (disposition), BW (body weight), BG (body-weight gain), FW (food/water), CL (clinical observations), LB (laboratory), MA/MI (macroscopic/microscopic pathology), OM (organ measurements), PM, PC/PP (toxicokinetics), EG (ECG), VS, DD (death diagnosis).
Relationships/supp: RELREC, SUPPQUAL, POOLDEF as applicable.

4. Key Conformance Notes

Datasets are SEND IG 3.1-conformant; a Define-XML 2.1 and this nSDRG accompany the datasets.
Validation was performed with an FDA-recognized validator (Pinnacle 21-equivalent); no blocking errors. Any reported warnings (e.g., sparse optional domains, controlled-terminology version notes) are explained in §5.
Controlled terminology corresponds to the submission-cited CDISC CT version; units and tests use CDISC standard terminology.

5. Known Issues and Explanations `[MOCK]`

Toxicokinetics (PC/PP): sparse sampling in some satellite groups results in expected "low-N" validator warnings; these are by design and not data errors.
Carcinogenicity tumor data: neoplastic findings (notably thyroid C-cell hyperplasia/adenoma in rats) are coded in MI with appropriate severity/incidence; the human-relevance assessment is presented in M4-2.3 and the carcinogenicity assessment (QA-003 ISS-012), not in the datasets.
No subject-level data were excluded; all randomized/assigned animals are represented.

6. Traceability

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).