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Volumn 13, Issue 12, 2008, Pages 681-690

Quality by design applications in biosimilar pharmaceutical products

Author keywords

Analytical methods; Biosimilars; Design of experiments; Multivariate methods; Quality by design; Simulation experiments; Specification limits

Indexed keywords


EID: 57349185727     PISSN: 09491775     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00769-008-0459-6     Document Type: Review
Times cited : (38)

References (25)
  • 2
    • 40149111537 scopus 로고    scopus 로고
    • Available online at:
    • Borman P, Nethercote P, Chatfield M, Thompson D, Truman K (2007) Pharm Technol. Available online at: http://pharmtech.findpharma.com/pharmtech/Peer- Reviewed+Research/The-Application-of-Quality-by-Design-to-Analytical/ ArticleStandard/Article/detail/463580
    • (2007) Pharm Technol
    • Borman, P.1    Nethercote, P.2    Chatfield, M.3    Thompson, D.4    Truman, K.5
  • 3
    • 57349120369 scopus 로고    scopus 로고
    • Available online at:
    • Cook S, Patton KA, Bazemore LR (2007) BioPharm Int 20(12):28-37. Available online at: http://biopharminternational.findpharma.com/biopharm/ Outsourcing/Quality-by-Design-in-the-CMO-Environment/ArticleStandard/Article/ detail/478714
    • (2007) BioPharm Int , vol.20 , Issue.12 , pp. 28-37
    • Cook, S.1    Patton, K.A.2    Bazemore, L.R.3
  • 15
    • 35348893976 scopus 로고    scopus 로고
    • Quality by Design (QbD) - A modern system approach to pharmaceutical development and manufacturing: FDA perspective
    • Maryland
    • Nasr M (2007) Quality by Design (QbD) - a modern system approach to pharmaceutical development and manufacturing: FDA perspective. FDA Quality Initiatives Workshop, Maryland
    • (2007) FDA Quality Initiatives Workshop
    • Nasr, M.1
  • 16
    • 57349120368 scopus 로고    scopus 로고
    • Implications of QbD approach on analytical method development, validation, transfer and change control
    • Frankfurt, Germany, April 2008. University of Wisconsin, School of Pharmacy, Madison
    • Nethercote P (2008) Implications of QbD approach on analytical method development, validation, transfer and change control. In: Proceedings of the Global Pharmaceutical Conference on Practical Application of QbD in Accelerated Development, Frankfurt, Germany, April 2008. University of Wisconsin, School of Pharmacy, Madison
    • (2008) Proceedings of the Global Pharmaceutical Conference on Practical Application of QbD in Accelerated Development
    • Nethercote, P.1
  • 25
    • 43349088601 scopus 로고    scopus 로고
    • 4
    • L Yu 2008 Pharm Res 25 4 781 791
    • (2008) Pharm Res , vol.25 , pp. 781-791
    • Yu, L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.