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Volumn 31, Issue 3, 1997, Pages 639-646

Development of stereoisomeric (chiral) drugs: A brief review of scientific and regulatory considerations

Author keywords

Chiral; Guidelines; Pharmaceuticals; Regulatory; Stereoisomers

Indexed keywords

ARTICLE; DRUG APPROVAL; DRUG INDUSTRY; DRUG MARKETING; DRUG STRUCTURE; ENANTIOMER; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; RACEMIC MIXTURE; STEREOISOMERISM; UNITED STATES;

EID: 0030800069     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159703100303     Document Type: Article
Times cited : (27)

References (10)
  • 2
    • 0029160945 scopus 로고
    • Development of chiral drugs in Japan: An update on regulatory and industrial opinion
    • Shindo H, Caldwell J. Development of chiral drugs in Japan: an update on regulatory and industrial opinion. Chirality. 1995;7:349-352.
    • (1995) Chirality , vol.7 , pp. 349-352
    • Shindo, H.1    Caldwell, J.2
  • 3
    • 1842301194 scopus 로고
    • Health Protection Branch Working Group on Drug Stereochemistry, Health and Welfare Canada; December
    • Guidelines on the development of stereoisomeric drugs (draft). Health Protection Branch Working Group on Drug Stereochemistry, Health and Welfare Canada; December 1993.
    • (1993) Guidelines on the Development of Stereoisomeric Drugs (Draft)
  • 6
    • 0028128074 scopus 로고
    • Stereoisomeric drugs: FDA's policy statement and the impact on drug development
    • Tomaszewski J, Rumore M. Stereoisomeric drugs: FDA's policy statement and the impact on drug development. Drug Devel Ind Pharm. 1994;20:119-139.
    • (1994) Drug Devel Ind Pharm. , vol.20 , pp. 119-139
    • Tomaszewski, J.1    Rumore, M.2
  • 9
    • 0028322316 scopus 로고
    • Incoming guidelines on chirality. A challenge for pharmacokinetics in drug development
    • Marzo A. Incoming guidelines on chirality. A challenge for pharmacokinetics in drug development. Arzneim Forsch. 1994;44:791-793.
    • (1994) Arzneim Forsch. , vol.44 , pp. 791-793
    • Marzo, A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.