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Volumn 16, Issue 3, 2011, Pages 16-24

Quality by design: A lifecycle concept for pharmaceutical analysis

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ANALYTIC METHOD; ANALYTICAL PARAMETERS; ANALYTICAL TARGET PROFILE; CHANGE MANAGEMENT; DRUG MANUFACTURE; INFORMATION; MATHEMATICAL COMPUTING; MEASUREMENT ERROR; PRACTICE GUIDELINE; PROCESS CONTROL; PROCESS DESIGN; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; PRODUCT DEVELOPMENT; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; VALIDATION PROCESS;

EID: 82755165373     PISSN: 13608606     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review
Times cited : (11)

References (20)
  • 4
    • 82755170727 scopus 로고    scopus 로고
    • ICH Q11: Development and Manufacture of Drug Substances (chemical entities and biotechnological/biological entities)
    • ICH Q11: Development and Manufacture of Drug Substances (chemical entities and biotechnological/biological entities) Draft Pre Step 2 (2010)10
    • (2010) Draft Pre Step , vol.2 , pp. 10
  • 6
    • 37749005415 scopus 로고    scopus 로고
    • A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603)
    • P.F. Gavin, B.A. Olsen, A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603). J.Pharm.Biomed.Anal. 46 (2008) 431-41
    • (2008) J.Pharm.Biomed.Anal. , vol.46 , pp. 431-441
    • Gavin, P.F.1    Olsen, B.A.2
  • 13
    • 34249083153 scopus 로고    scopus 로고
    • A total error approach for the validation of quantitative analytical methods
    • DOI 10.1007/s11095-007-9242-3
    • D. Huffman, R. Kringle, A total error approach for the validation of quantitative analytical methods. Pharm.Res. 24 (2007) 1157-64 (Pubitemid 46798895)
    • (2007) Pharmaceutical Research , vol.24 , Issue.6 , pp. 1157-1164
    • Hoffman, D.1    Kringle, R.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.