Module 2.7.5 — Literature References (TILA-278)
📚 Part of the TILA-278 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 (TILA-278)
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 (TILA-278)
Document ID: M275
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH M4E(R2)
2.7.5 Literature References — TILA-278
Key references cited across the clinical summaries for TILA-278 in Ulcerative Colitis (moderate-to-severe), including the disease epidemiology and unmet need, the bispecific monoclonal antibody mechanism and class data, the endpoint validation (Modified Mayo Score), and the relevant regulatory guidance. Full citations accompany each Module 2.5/2.7 and Module 5 document.
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