Journal of Integrative Natural Science (통합자연과학논문집)

The Basic Science Institute Chosun University (조선대학교 기초과학연구원)
권호 표지
DOI QR코드

DOI QR Code

Investigation of New Drug Submission Documents for the Safety and Efficacy Evaluation of Stereoisomeric Drugs

광학이성질체 의약품의 안전성과 유효성 측면에서 의약품 허가신청 자료에 대한 비교연구

  • 김광준 (조선대학교 약학대학 약학과) ;
  • 최인 (조선대학교병원 약제부) ;
  • 이범규 (조선대학교 자연과학대학 화학과) ;
  • 문홍섭 (목포대학교 약학대학 약학과) ;
  • 한효경 (동국대학교 약학대학 약학과) ;
  • 최은주 (조선대학교 약학대학 약학과) ;
  • 이원재 (조선대학교 약학대학 약학과)
  • Received : 2011.09.20
  • Accepted : 2011.12.22
  • Published : 2011.12.30
Download PDF
⟨ Previous Next ⟩

Abstract

This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the approval of stereoisomeric drugs in Korea and US. According to the regulatory guidelines in major countries (EU, Canada, US), the important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substances 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. For this study, domestic regulatory documents for current guidelines of stereoisomeric drugs were investigated. Also four typical stereoisomeric drugs for three categories were chosen to investigate the new drug submission documents of KFDA and FDA for the safety and efficacy evaluation of stereoisomeric drugs. It is expected that these comparative results between KFDA and FDA will be useful for the safety and efficacy for the regulatory approval of stereoisomeric drugs in Korea.

Keywords

References

  1. C. A. Challener, "Chiral drugs", Aldershot, Ashgate Publishing, pp. 15-25, 2002.
  2. L. A. Nguyen, H. He, and C. Pham-Huy, "Chiral drugs, an overview", Int. J. Biomed. Sci., Vol. 2, pp. 85-100, 2006.
  3. G. Subramanian, "A practical approach to chiral separations by liquid chromatography", Weinheim, VCH, pp. 63-70, 1994.
  4. J. R. Brown, "Regulatory implications and chiral separations, In: A practical approach to chiral separations by liquid chromatography (Ed.: Subramanian, G.)", Weinheim, VCH, pp. 57-62. 1994,
  5. J. M. Daniels, E. R. Nestmann, and A. Kerr, "Development of stereoisomeric (chiral) drugs: a brief review of scientific and regulatory considerations", J. Drug Infor., Vol. 31, pp. 639-646, 1997. https://doi.org/10.1177/009286159703100303
  6. N. R. Srinivas, R. H. Barbhaiya, and K. K. Midha, "Enantiomeric drug development: issues, considerations, and regulatory requirements", J. Pharm. Sci., Vol. 90, pp. 1205-1215, 2001. https://doi.org/10.1002/jps.1074
  7. I. K. Reddy and R. Mehvar, "Chirality in drug design and development", Marcel Dekker, New York, pp. 419-432, 2004.
  8. FDA's policy statement for the development of new stereoisomeric drugs. Chirality, Vol. 4, pp. 338-340, 1992. https://doi.org/10.1002/chir.530040513
  9. FDA Drug guidances, "Development of new stereoisomeric drugs", July 6, 2005, Internet site : http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122883.htm
  10. Investigation of chiral active substances (CPMP/III/ 3501/91). Internet site: http://www.ema.europa.eu/ docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002816.pdf
  11. Guidance for Industry : Stereochemical Issues in Chiral Drug Development.Therapeutic Products Programme. Health Canada (May 1, 2000). Internet site: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/ applic-demande/guide-ld/chem/stereo-eng.php
  12. FDA Drug guidances: Development of new stereoisomeric drugs. (July 6, 2005), Internet site : http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122883.htm
  13. O. C. Sun, H. J. Sung, Y. U. So, J. J. Seo, I. K. Joo, and Y. C. Soo, "tereochemical Issues in Chiral Drug Development", J. Kor. Pharm. Sci., Vol. 35, pp. 57-63, 2005.
  14. 식품의약품안전청 공고 제 2008 - 82호, "의약품등의 품목허가신고심사규정", May 2, 2008, Internet site: http://kfda.go.kr/index.kfda?mid=54&seq=3742
  15. 의약품안전국, "K의약품등의 안전성유효성 심사 관련해설서", 식품의약품안전청, 2008.
  16. 미국 식품의약청 안전청 Internet site: http://www.fda.gov/Drugs/default.htm
  17. International Federation of Pharmaceutical Manufactures Associations; IFPMA internet site : www.ifpma.org
  18. Q6A International Conference on Harmonisation; Guidance on Q6A International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceutical Human Use, Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products : Chemical Substances, May, 2000, (CPMP/ICH/367/96) internet site: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC 500002823.pdf