임상시험계획승인신청(IND) 요약 — GLPI-103 (MFDS)
📚 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. A summary of the Korean clinical-trial application (IND) filed with the MFDS (Ministry of Food and Drug Safety).
Why it exists. Korea requires MFDS approval of the trial plan before a clinical study may start. This document is the Korean-language administrative and scientific summary supporting that approval.
How it is produced here. This is a region-specific administrative document, assembled to the local filing and labeling conventions. Its operational and label content is written to stay consistent with the (simulated) clinical data.
Format & governing standard. 약사법 / 의약품 임상시험 계획 승인(IND) 규정
임상시험계획승인신청(IND) 요약 — GLPI-103 (MFDS)
| Field | Value |
|---|---|
| Document ID | IND-KR |
| Version | 1.0 |
| Region | MFDS (Korea) |
| Standard | 약사법 / 의약품 임상시험 계획 승인(IND) 규정 |
| Confidentiality | Confidential — portfolio use |
국내 임상시험 실시를 위한 임상시험계획승인(IND) 신청 요약. 행정 식별자는
[MOCK].
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | 한국 RA | 초판 |
구성
- 품질자료(CMC): 원료의약품·완제의약품 — Module 3(M3).
- 비임상자료: 약리·약동·독성 요약(M2.4/M2.6; M4)으로 임상 용량 정당화.
- 임상자료: 임상시험계획서(PROT-301), 시험자자료집(IB-001), 기존 임상경험(CSR-101/102/201).
- 유익성-위해성: M2.5.6 참조.
안전성 보고 및 관리
중대 이상약물반응(SUSAR) 신속보고 및 정기보고를 약사법령에 따라 수행하며, 안전성 관리 계획(TMF-SMP) 및 위해성 관리 계획(RMP-KR)과 연계한다.
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