메뉴 건너뛰기




Volumn 54, Issue 1, 2008, Pages 23-29

Present state of new chiral drug development and review in Japan

Author keywords

Chiral drug; Guideline; Pharmaceutical development; Racemic drug; Single enantiomer drug

Indexed keywords

NEW DRUG;

EID: 44449126537     PISSN: 13449702     EISSN: 13475207     Source Type: Journal    
DOI: 10.1248/jhs.54.23     Document Type: Article
Times cited : (49)

References (16)
  • 1
    • 44449147258 scopus 로고    scopus 로고
    • The United States Adopted Names (USAN) Council in The American Medical Association AMA
    • The United States Adopted Names (USAN) Council in The American Medical Association (AMA) (2005) Geometric isomerism and chirality: The USAN perspective, http://www.amaassn.org/ama/pub/category/15698.html
    • (2005) Geometric isomerism and chirality: The USAN perspective
  • 2
    • 0003735680 scopus 로고    scopus 로고
    • Counting on chirality
    • Stinson, S. (1998) Counting on chirality. Chem. Eng. News, 76(38), 83-104.
    • (1998) Chem. Eng. News , vol.76 , Issue.38 , pp. 83-104
    • Stinson, S.1
  • 3
    • 25544431877 scopus 로고    scopus 로고
    • Chiral business
    • Rouhi, A. M. (2003) Chiral business. Chem. Eng. News, 81(18), 45-55.
    • (2003) Chem. Eng. News , vol.81 , Issue.18 , pp. 45-55
    • Rouhi, A.M.1
  • 5
    • 44449111477 scopus 로고    scopus 로고
    • Pharmaceuticals and Medical Devices Agency April 2001-present
    • Pharmaceuticals and Medical Devices Agency (April 2001-present) Information for approved drugs in Japan, http://www.info.pmda.go.jp/ shinyaku/shinyaku index.html
    • Information for approved drugs in Japan
  • 6
    • 44449103923 scopus 로고    scopus 로고
    • Pharmaceuticals and Medical Devices Agency September 1999-October
    • Pharmaceuticals and Medical Devices Agency (September 1999-October 2005) Information for approved drugs in Japan, http://www.jpec.or.jp/contents/ c01/link.html
    • (2005) Information for approved drugs in Japan
  • 7
    • 44449089711 scopus 로고
    • FDA's policy statement for the development of new stereoisomeric drugs
    • Food and Drug Administration (1992) FDA's policy statement for the development of new stereoisomeric drugs. US Food and Drug Administration regulatory guidance, http://www.fda.gov/cder/guidance/stereo.htm
    • (1992) US Food and Drug Administration regulatory guidance
  • 8
    • 44449131828 scopus 로고    scopus 로고
    • Health Canada (2000) Stereochemical issues in chiral drug development. Health Canada guidance document, http://www.hc-sc.gc.ca/dhp-mps/ prodpharma/applic-demande/guide-ld/chem/stereoe.html
    • Health Canada (2000) Stereochemical issues in chiral drug development. Health Canada guidance document, http://www.hc-sc.gc.ca/dhp-mps/ prodpharma/applic-demande/guide-ld/chem/stereoe.html
  • 10
    • 44449100893 scopus 로고    scopus 로고
    • International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Human Use (1999) Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances, Q6A, Step 4, ICH
    • International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Human Use (1999) Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances, Q6A, Step 4, ICH, http://www.ich.org/cache/ compo/363-272-1.html#Q6A
  • 11
    • 44449159073 scopus 로고    scopus 로고
    • Ministry of Health, Labour and Welfare (2001) Setting of Specifications and Test Methods of New Drugs, Notification No.568 of the Evaluation and Licensing Division, PMSB dated May 1, 2001, http://www.pmda.go. jp/ich/q/q6a 01 5 1.pdf
    • Ministry of Health, Labour and Welfare (2001) Setting of Specifications and Test Methods of New Drugs, Notification No.568 of the Evaluation and Licensing Division, PMSB dated May 1, 2001, http://www.pmda.go. jp/ich/q/q6a 01 5 1.pdf
  • 12
    • 44449170123 scopus 로고    scopus 로고
    • Ministry of Health and Welfare (1994) Guidelines for Establishment of Specifications and Test Methods for New Drugs, Notification No. 586 of the Pharmaceuticals and Cosmetics Division, PAB dated September 1, 1994.
    • Ministry of Health and Welfare (1994) Guidelines for Establishment of Specifications and Test Methods for New Drugs, Notification No. 586 of the Pharmaceuticals and Cosmetics Division, PAB dated September 1, 1994.
  • 13
    • 0005995974 scopus 로고    scopus 로고
    • International regulation of chiral drugs
    • 2nd Edition Subramanian, G, Ed, Wiley-VCH, Weinheim, pp
    • Branch, S. K. (2001) International regulation of chiral drugs. In Chiral Separation Techniques. A Practical Approach, 2nd Edition (Subramanian, G., Ed.) Wiley-VCH, Weinheim, pp. 319-342.
    • (2001) Chiral Separation Techniques. A Practical Approach , pp. 319-342
    • Branch, S.K.1
  • 14
    • 0029160945 scopus 로고
    • Development of chiral drugs in Japan: An update on regulatory and industrial opinion
    • Shindo, H. and Caldwell, J. (1995) Development of chiral drugs in Japan: an update on regulatory and industrial opinion. Chirality, 7, 349-352.
    • (1995) Chirality , vol.7 , pp. 349-352
    • Shindo, H.1    Caldwell, J.2
  • 15
    • 0025765543 scopus 로고
    • Regulatory aspects of the development of chiral drugs in Japan: A status report
    • Shindo, H. and Caldwell, J. (1991) Regulatory aspects of the development of chiral drugs in Japan: a status report. Chirality, 3, 91-93.
    • (1991) Chirality , vol.3 , pp. 91-93
    • Shindo, H.1    Caldwell, J.2
  • 16
    • 44449124368 scopus 로고    scopus 로고
    • Ministry of Health, Labour and Welfare (1998) Guidelines on Non-clinical Pharmacokinetic Studies, Notification No. 496 of the Evaluation and Licensing Division, PMSB dated June 26, 1998, http://www.nihs.go.jp/mhlw/ tuuchi/1998/980626/980626.pdf
    • Ministry of Health, Labour and Welfare (1998) Guidelines on Non-clinical Pharmacokinetic Studies, Notification No. 496 of the Evaluation and Licensing Division, PMSB dated June 26, 1998, http://www.nihs.go.jp/mhlw/ tuuchi/1998/980626/980626.pdf


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.