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Volumn 8, Issue 6, 2010, Pages 22-30

Practical considerations for DoE implementation in quality by design

Author keywords

Critical process parameters; Critical Quality Attributes (CQAs); Modeling; Process optimization; Statistical analysis; Variation

Indexed keywords

ANALYSIS OF VARIANCE; BIOPROCESS; COMPUTER INTERFACE; COMPUTER PROGRAM; CONFOUNDING VARIABLE; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; EXPERIMENTAL DESIGN; FACTORIAL DESIGN; GOOD MANUFACTURING PRACTICE; HEALTH CARE AVAILABILITY; HUMAN; MEASUREMENT ERROR; PROCESS DESIGN; PROCESS DEVELOPMENT; PRODUCT DEVELOPMENT; QUALITY CONTROL; REPRODUCIBILITY; RESOURCE ALLOCATION; REVIEW; RISK ASSESSMENT; RISK MANAGEMENT;

EID: 77955411444     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review
Times cited : (45)

References (13)
  • 1
    • 77955369990 scopus 로고    scopus 로고
    • ICH Q8: Pharmaceutical Development
    • ICH Q8: Pharmaceutical Development. Fed. Reg. 71(98) 2006; www.ich.org/LOB/media/MEDIA4986.pdf.
    • (2006) Fed. Reg. , vol.71 , Issue.98
  • 3
    • 77951629609 scopus 로고    scopus 로고
    • QbD: Convincing the Skeptics
    • May
    • Torbeck L, Branning R. QbD: Convincing the Skeptics. BioPharm Int. May 2009: 52-58.
    • (2009) BioPharm Int. , pp. 52-58
    • Torbeck, L.1    Branning, R.2
  • 4
    • 2542454009 scopus 로고    scopus 로고
    • A strategic methodology to the use of advanced statistical quality improvement techniques
    • Antony J, Kaye M, Frangou A. A Strategic Methodology to the Use of Advanced Statistical Quality Improvement Techniques. The TQM Magazine 10(3) 1998: 169-176. (Pubitemid 128522691)
    • (1998) TQM Magazine , vol.10 , Issue.3 , pp. 169-176
    • Antony, J.1    Kaye, M.2    Frangou, A.3
  • 5
    • 57349120369 scopus 로고    scopus 로고
    • Quality by Design in the CMO Environment
    • December
    • Cook S, Patton KA, Bazemore R. Quality By Design in the CMO Environment. BioPharm Int. December 2007: 28-46.
    • (2007) BioPharm Int. , pp. 28-46
    • Cook, S.1    Patton, K.A.2    Bazemore, R.3
  • 6
    • 60149106150 scopus 로고    scopus 로고
    • Quality by Design for Biopharmaceuticals
    • Rathore AS, Winkle H. Quality By Design for Biopharmaceuticals. Nat. Biotechnol. 27(1) 2009: 26-34.
    • (2009) Nat. Biotechnol. , vol.27 , Issue.1 , pp. 26-34
    • Rathore, A.S.1    Winkle, H.2
  • 7
    • 33745601149 scopus 로고    scopus 로고
    • ICH Q9: Quality Risk Management
    • ICH Q9: Quality Risk Management. Fed. Reg. 71(106) 2006: 32105-32106; www.ich.org/LOB/media/MEDIA1957.pdf.
    • (2006) Fed. Reg. , vol.71 , Issue.106 , pp. 32105-32106
  • 8
    • 77955407279 scopus 로고    scopus 로고
    • Eight Ways to Clean an Experiment
    • American Society for Quality: Milwaukee, WI
    • Kraber S. Eight Ways to Clean an Experiment. AQC World Congress 1998.American Society for Quality: Milwaukee, WI, 1998.
    • (1998) AQC World Congress 1998
    • Kraber, S.1
  • 11
    • 33847156852 scopus 로고    scopus 로고
    • Using Statistical Analysis for Setting Process Validation Acceptance Criteria for Biotech Products
    • Wang XGA, Harms J, Rathore AS. Using Statistical Analysis for Setting Process Validation Acceptance Criteria for Biotech Products. J. Biotechnol. Progr. 53, 2007: 55-60.
    • (2007) J. Biotechnol. Progr. , vol.53 , pp. 55-60
    • Wang, X.G.A.1    Harms, J.2    Rathore, A.S.3
  • 12
    • 33847173754 scopus 로고    scopus 로고
    • Application of Multivariate Analysis Toward Biotech Processes: Case Study of a Cell Culture Unit Operation
    • Kirdar AO, Baclaski J, Rathore AS. Application of Multivariate Analysis Toward Biotech Processes: Case Study of a Cell Culture Unit Operation. J. Biotechnol. Progr. 23, 2007: 61-67.
    • (2007) J. Biotechnol. Progr. , vol.23 , pp. 61-67
    • Kirdar, A.O.1    Baclaski, J.2    Rathore, A.S.3
  • 13
    • 77955386982 scopus 로고    scopus 로고
    • Webinar Series
    • Adams W. Replicates vs. Repeats. Webinar Series, 2008. Stat-Ease Inc.: www.statease.com/webinar.html.
    • (2008) Replicates Vs. Repeats
    • Adams, W.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.