Nuclear Medicine and Molecular Imaging

The Korean Society of Nuclear Medicine (대한핵의학회)
권호 표지

Suggestions for Radiopharmaceutical Drug Development in Korea Focusing on FDA Exploratory IND Guideline

FDA exploratory IND의 기준을 중심으로 본 국내 방사성 의약품 기술개발을 위한 제언

  • Ryu, Young-Hoon (Department of Nuclear Medicine, Yonsei University, Medical College) ;
  • Choi, Tae-Hyun (Radiological and Medical Sciences Research Center, Korea Institute of Radiological and Medical Sciences)
  • 유영훈 (연세대학교 의과대학 영상의학교실 핵의학과) ;
  • 최태현 (한국원자력의학원 방사선의학연구소 핵의학 RI 연구부 동위원소생산평가기술개발팀)
  • Published : 2007.12.31
Download PDF
⟨ Previous Next ⟩

Abstract

Regulation for the radiopharmaceuticals should be reasonably different from that of other drugs. Radiopharmaceuticals are always used by compounding based on the doctor's order, have short half life and very low administration dose. Its pharmacological effect is not from its chemical effect but from radiation. The background for exploratory IND (Investigational New Drug) explained by the FDA was to reduce the time and resources expended on candidate products that are unlikely to suceed, new tools are needed to distinguish earlier in the process those candidates that hold promise from those that do not. In this review, basic concept for exploratory IND and RDRC guideline is summarized and various suggestions for improving and expediting procedure for new radiopharmaceutical development would be described.

Keywords

References

  1. Vanbrocklin HF. FDA requests community input on RDRC and the exploratory IND. www.snidd.org/newsletters/NewsletterSummer05.pdf
  2. US Department of Health and Human Services Food and Drug Administration. Innovation or Stagnation. www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
  3. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies. http://www.fda.gov/cder/guidance/7086fnl.htm
  4. 대한핵의학회 방사성의약품위원회. 방사성의약품 제조관리 지침서 발간 및 평가기준 설정 2006
  5. European Medicines Agency (EMEA), Evaluation of Medicines for Human Use, 'Position Paper on Non-Clinical Safety Studies to Support Clinical Trials with a Single Microdose,' CPMP/SWP/2599/ 02Rev 1
  6. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Product. www.fda.gov/CDER/GUIDANCE/phase1.pdf
  7. Suleiman OH, Fejka R, Houn F, Walsh M. The radioactive drug research committee: Background and retrospective study of reported research data (1975-2004). J Nucl Med 2006;47:1220-6
  8. Suleiman OH, Fejka R. The Radioactive Drug Research Committee: A 2007 update.(abstract) J Nucl Med 2007;48:327