Module 2.7.5 — Literature References
📚 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 list of literature references cited across the clinical summaries.
Why it exists. Claims in the clinical summaries must be traceable to their sources — published literature and the study reports. Module 2.7.5 is the bibliography that supports the arguments made in 2.5 and 2.7.
How it is produced here. It contains no new data. It is a distillation — it gathers, summarizes, and cross-references the underlying study reports and datasets into the shorter form a regulator reads first.
Format & governing standard. ICH M4E(R2) §2.7.5
Module 2.7.5 — Literature References
| Field | Value |
|---|---|
| Document ID | M275 |
| Version | 1.0 |
| Compound | GLPI-103 (GLP-1/APJ dual agonist) |
| Standard | ICH M4E(R2) §2.7.5 |
| Confidentiality | Confidential |
References cited in the Clinical Summary (2.7.1–2.7.4) and Clinical Overview (2.5).
[MOCK]placeholder citations representative of the field; full bibliographic details would be provided in an actual submission.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Medical Writing | Initial reference list |
References [MOCK]
- ICH E3 — Structure and Content of Clinical Study Reports.
- ICH E6(R3) — Good Clinical Practice.
- ICH E9 and E9(R1) — Statistical Principles; Estimands and Sensitivity Analysis.
- ADA/EASD Consensus Report on the Management of Hyperglycaemia in Type 2 Diabetes (current).
- KDA (Korean Diabetes Association) Clinical Practice Guidelines (current).
- Pivotal trials of GLP-1 receptor agonists (e.g., semaglutide SUSTAIN/PIONEER; tirzepatide SURPASS) — comparator efficacy/safety context.
- Apelin/APJ pathway in cardiometabolic disease — mechanistic literature.
- KNHANES / NHIS — epidemiology of T2DM in the Korean population (demographic basis; REF-002).
- CDISC SDTM-IG, ADaM-IG, Define-XML v2.1.
Internal study reports: PROT-301, SAP-301, CSR-301, CSR-101/102/201, IB-001 (cross-referenced throughout Module 2).
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