Abstract ▼

○ Purpose: Preclinical and phase I clinical trial of peptide receptor radionuclide therapy in patients with retractable/advanced neuroendocrine tumor

○ Contents
1. Carriy out nonclinical studies and approve clinical trial phase 1 for radiopharmaceuticals
2. Establish Lu-177-based radiop

○ Purpose: Preclinical and phase I clinical trial of peptide receptor radionuclide therapy in patients with retractable/advanced neuroendocrine tumor

○ Contents
1. Carriy out nonclinical studies and approve clinical trial phase 1 for radiopharmaceuticals
2. Establish Lu-177-based radiopharmaceutical production system and obtain GMP certificate
3. Carry out Phase I clinical trial for safety evaluation and get approval for phase II clinical trial of radiopharmaceuticals
4. Production and quality control of Lu-177-based therapeutic radiopharmaceuticals

○ Development Results and contribution
1. Since there are scattered experts and facilities of nuclear medicine in the whole country, it spreads to the whole country using the radioisotope production facility and R & D base established through this study.
2. Based on the experience gained in the IND approval process of therapeutic radiolabeled synthetic labeling drugs, this study will serve as a useful base for the practical use of synthetic drugs to be developed in the future
3. Can be used as a new growth engine for 4th industry by securing synthesis platform and manufacturing technology for radioisotope labeled synthetic drug development
4. It is anticipated that by using the therapeutic radioisotope labeled synthetic drug pipeline established through this study, it will be possible to develop a therapeutic product with a small quantity production strategy of multiple products for the rare cancer patients who are alienated from the existing therapeutic drug development market

(source : SUMMARY 6p)

목차 Contents

• 표지 ... 1
• 제출문 ... 2
• 보고서 요약서 ... 3
• 요약문 ... 5
• SUMMARY ... 6
• 6.1 총괄연구개발과제의 연구성과 실적 및 향후 계획 ... 7
• 6.2 연구성과 유형별 세부 내역 ... 9
• 7. 참여연구원 현황표 ... 15
• 목차 ... 16
• 1. 연구개발과제의 개요 ... 17
• 2. 연구개발과제의 수행 과정 및 수행 내용 ... 20
• 3. 연구개발과제의 수행 결과 및 목표 달성 정도 ... 34
• 1) 연구수행 결과 ... 34
• 2) 목표 달성 수준 ... 41
• 4. 목표 미달 시 원인분석 ... 42
• 1) 목표 미달 원인(사유) 자체분석 내용 ... 42
• 2) 자체 보완활동 ... 42
• 3) 연구개발 과정의 성실성 ... 42
• 5. 연구개발성과의 관련 분야에 대한 기여 정도 ... 42
• 6. 연구개발성과의 관리 및 활용 계획 ... 43
• 7. 참고문헌 ... 43
• 끝페이지 ... 46