Module 2.7.5 — Literature References (OBX-319)
📚 Part of the OBX-319 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. Module 2.7.5 — Literature References (OBX-319)
Why it exists. A high-level CTD summary a reviewer reads first; it distils the underlying reports.
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. —
Module 2.7.5 — Literature References (OBX-319)
Document ID: M275
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH M4E(R2)
2.7.5 Literature References — OBX-319
Key references cited across the clinical summaries for OBX-319 in Systemic Lupus Erythematosus (moderate-to-severe active), including the disease epidemiology and unmet need, the bispecific monoclonal antibody mechanism and class data, the endpoint validation (SLEDAI-2K), and the relevant regulatory guidance. Full citations accompany each Module 2.5/2.7 and Module 5 document.
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