Regulatory Requirements on the Safety and Efficacy Evaluation for the Development of Stereoisomeric Drugs |
Kim, Kwang-Joon
(College of Pharmacy, Chosun University)
Choi, In (Department of Pharmacy, Chosun University Hospital) Seo, Kyu-Hwa (College of Pharmacy, Chosun University) Han, Hyo-Kyung (College of Pharmacy, Dongguk University) Lee, Won-Jae (College of Pharmacy, Chosun University) |
1 | Somogyi, A., Bochner, F. and Foster, D. : Inside the isomers: the tale of chiral switches. Aust. Prescr. 27, 47 (2004). DOI |
2 | 식품의약품안전청 공고 제 2008 - 82호 의약품등의 품목허가 신고 심사 규정(2008년 5월 2일), Internet site: http:// kfda.go.kr/index.kfda?mid=54&seq=3742. |
3 | 의약품등의 안전성유효성 심사 관련 해설서, 2008년 12월, 의약 품안전국, 식품의약품안전청. |
4 | EUDRALEX : the rules governing medicinal products in the european union, Vol 1-9, Office for official publications of the european communities, Luxembourg (1998). |
5 | Scientific guidelines for medicinal products for human use. Internet site: http://www.it-asso.com/gxp/eudralex_v21/ contents/homev3.htm. |
6 | 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. |
7 | 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/stereoeng. php. |
8 | Shindo, H. and Caldwell, J. : Development of chiral drugs in Japan: an update on regulatory and industrial opinion. Chirality 7, 349 (1995). DOI ScienceOn |
9 | Shindo, H. and Caldwell, J. : Regulatory aspects of the development of chiral drugs in Japan: a status report. Chirality 3, 91 (1991). DOI |
10 | Shimazawa, R., Nagai, N., Toyoshima, S. and Okuda, H. : Present state of new chiral drug development and review in Japan. J. Health Science 54, 23 (2008). DOI ScienceOn |
11 | Fromm, G. H. and Terrence, C. F. : Comparison of L-baclofen and racemic baclofen in trigeminal neuralgia. Neurology 37, 1725 (1987). DOI |
12 | Gristwood, R., Bardsley, H., Baker, H. and Dickens, J. : Reduced cardiotoxicity of levobupivacaine compared to racemic bupivacaine (Marcaine): new clinical evidence. Exp. Opin. Invest. Drugs. 3, 1209 (1994). |
13 | McClellan, K. J. and Spencer, C. M. : Levobupivacaine. Drugs. 56, 356 (1998). |
14 | Valenzuela, C., Snyders, D. J., Bennet, P. B., Tamargo, J. and Hongdeghem, L. M. : Stereoselective block of cardiac sodium channels by bupivacaine in guinea pig ventricular myocytes. Circulation. 92, 3014 (1995). DOI ScienceOn |
15 | Lee, W. : The application of chiral HPLC columns for enantiomer separation of chiral drugs. Yakhak Hoeji 53, 60 (2009). |
16 | Tucker, G. T. : Chiral switches. Lancet. 355, 1085 (2000). DOI ScienceOn |
17 | Caner, H., Groner, E., Levy, L. and Agranat, I. : Trends in the development of chiral drugs. Drug Discovery Today 9, 105 (2004). DOI ScienceOn |
18 | Nguyen, L. A., He, H. and Pham-Huy, C. : Chiral drugs, an overview. Int. J. Biomed. Sci. 2, 85 (2006). |
19 | Cayen, M. N. and Sahajwalla, C. : Development of stereoisomeric drugs, In: Drug stereochemistry (Ed.: I. W. Wainer). New York, Marcel Dekker, p 399-410 (1993). |
20 | Hutt, A. J. : The development of single-isomer molecules: why and how. CNS Spectr. 7(Suppl. 1), 14 (2002). DOI |
21 | Sahajwalla, C. : Regulatory considerations in drug development of stereoisomers, In: Chirality in drug design and development (Ed.: I. K. Reddy, R. Mehvar). New York, Marcel Dekker, p 419-432 (2004). |
22 | Srinivas, N. R., Barbhaiya, R. H. and Midha, K. K. : Enantiomeric drug development: issues, considerations, and regulatory requirements. J. Pharm. Sci. 90, 1205 (2001) DOI ScienceOn |
23 | Daniels, J. M., Nestmann, E. R. and Kerr, A. : Development of stereoisomeric (chiral) drugs: a brief review of scientific and regulatory considerations. Drug Infor. J. 31, 639 (1997). DOI |
24 | Rauws, A. G. and Groen, K. : Current regulatory (draft) guidance on chiral medicinal products: Canada, EEC, Japan, United States. Chirality 6, 72 (1994). DOI ScienceOn |
25 | FDA's policy statement for the development of new stereoisomeric drugs. Chirality 4, 338 (1992). DOI ScienceOn |
26 | FDA Drug guidances: Development of new stereoisomeric drugs. (July 6, 2005), Internet site: http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ ucm122883.htm. |