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).