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

목차 (Table of Contents)

• Abstract
• 1. 서론
• 2. 연구 결과 및 토의
• 2.1. 국내의 광학이성질체 의약품 허가신청을 위한안전성 유효성 평가 제출서류의 범위
• 2.2. KFDA와 FDA에 제출된 안전성, 유효성 평가자료의 비교 연구
• 3. 결론
• 감사의 글
• 참고문헌

참고문헌 (Reference)

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2 "미국 식품의약청 안전청"

3 최선옥, "광학활성의약품 개발과정에서의 입체화학적 문제" 한국약제학회 35 (35): 57-63, 2005

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5 FDA Drug guidances: Development of new stereoisomeric drugs, "http:// www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm122883.htm"

6 Guidance for Industry : Stereochemical Issues in Chiral Drug Development, "Therapeutic Products Programme"

7 J. R. Brown, "Regulatory implications and chiral separations, In: A practical approach to chiral separations by liquid chromatography" Weinheim, VCH 57-62, 1994

8 의약품안전국, "K의약품등의 안전성유효성 심사 관 련해설서"

9 "International Federation of Pharmaceutical Manufactures Associations" IFPMA internet site

10 Q6A International Conference on Harmonisation, "Guidance on Q6A International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceutical Human Use" Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products

11 N. R. Srinivas, "Enantiomeric drug development: issues, considerations, and regulatory requirements" 90 : 1205-1215, 2001

12 J. M. Daniels, "Development of stereoisomeric (chiral) drugs: a brief review of scientific and regulatory considerations" 31 : 639-646, 1997

13 FDA Drug guidances, "Development of new stereoisomeric drugs"

14 FDA's policy statement for the development of new stereoisomeric drugs, "Chirality, Vol. 4" 338-340, 1992

15 I. K. Reddy, "Chirality in drug design and development" Marcel Dekker, New York 419-432, 2004

16 L. A. Nguyen, "Chiral drugs, an overview" 2 : 85-100, 2006

17 C. A. Challener, "Chiral drugs" Aldershot, Ashgate Publishing 15-25, 2002

18 G. Subramanian, "A practical approach to chiral separations by liquid chromatography" Weinheim, VCH 63-70, 1994