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).