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Volumn 11, Issue 2, 2013, Pages 12-17

Implementation of quality by design in vaccine development

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY;

EID: 84874706500     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article
Times cited : (2)

References (20)
  • 3
    • 83755183352 scopus 로고    scopus 로고
    • How QbD and the FDA process validation guidance affect product development and operations
    • Calcott P. How QbD and the FDA Process Validation Guidance Affect Product Development and Operations. BioProcess Int. 9(10) 2011: 14-19.
    • (2011) BioProcess Int , vol.9 , Issue.10 , pp. 14-19
    • Calcott, P.1
  • 5
    • 46649115901 scopus 로고    scopus 로고
    • Defining your product profile. Maintaining control over It Part 1
    • Simmerman H, Donnelly RP. Defining Your Product Profile and Maintaining Control Over It, Part 1. BioProcess Intl. 3(6) 2005: 32-40.
    • (2005) BioProcess Intl , vol.3 , Issue.6 , pp. 32-40
    • Simmerman, H.1    Donnelly, R.P.2
  • 6
    • 37349012594 scopus 로고    scopus 로고
    • Defining your product profile and maintaining control over It Part 2
    • Champion K, et al. Defining Your Product Profile and Maintaining Control Over It, Part 2. BioProcess Intl. 3(8) 2005: 52-57.
    • (2005) BioProcess Intl , vol.3 , Issue.8 , pp. 52-57
    • Champion, K.1
  • 7
    • 34347206089 scopus 로고    scopus 로고
    • Defining your product profile maintaining control over it Part 3
    • Boerner R, Clouse K. Defining Your Product Profile and Maintaining Control Over It, Part 3. BioProcess Intl. 3(9) 2005: 50-56.
    • (2005) BioProcess Intl , vol.3 , Issue.9 , pp. 50-56
    • Boerner, R.1    Clouse, K.2
  • 8
    • 34347206089 scopus 로고    scopus 로고
    • Defining your product profile maintaining control over it Part 4
    • Brorson K, Phillips J. Defining Your Product Profile and Maintaining Control Over It, Part 4. BioProcess Intl. 3(10) 2005: 50-54.
    • (2005) BioProcess Intl , vol.3 , Issue.10 , pp. 50-54
    • Brorson, K.1    Phillips, J.2
  • 17
    • 57349185727 scopus 로고    scopus 로고
    • Quality by design applications in biosimilar technological products
    • Kenett RS, Kenett DA. Quality by Design Applications in Biosimilar Technological Products. Accreditation and Quality Assurance 13(12) 2008: 681-690.
    • (2008) Accreditation and Quality Assurance , vol.13 , Issue.12 , pp. 681-690
    • Kenett, R.S.1    Kenett, D.A.2
  • 18
    • 84868644472 scopus 로고    scopus 로고
    • QbD for biologics
    • 29
    • Kozlowski S, et al. QbD for Biologics. BioProcess Int. 10(8) 2012: 18-29; www.bioprocessintl.com/journal/2012/September/QbD-for-Biologics-334629.
    • (2012) BioProcess Int , vol.10 , Issue.8 , pp. 18-2012
    • Kozlowski, S.1
  • 19
    • 84874731391 scopus 로고    scopus 로고
    • Implementing quality by design
    • Winkle H. Implementing Quality by Design, PDA/FDA Conference 2007; www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm103453.pdf.
    • (2007) PDA/FDA Conference
    • Winkle, H.1
  • 20
    • 43349088601 scopus 로고    scopus 로고
    • Pharmaceutical quality by design: Product and process development, understanding, and control
    • Yu L. Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control. Pharm. Res. 25(4) 2008: 781-791.
    • (2008) Pharm. Res , vol.25 , Issue.4 , pp. 781-791
    • Yu, L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.