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Quality by Design for Biopharmaceuticals: Principles and Case Studies
Volumn , Issue , 2008, Pages 1-8
Quality by Design: An Overview of the Basic Concepts
Author keywords

Molecule critical quality attribute (CQA) understanding; Process analytical technology (PAT) and QbD; Quality by Design (QbD) and mechanism of action (MOA) and molecule safety
Indexed keywords

EID: 84889437744     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470466315.ch1     Document Type: Chapter
Times cited : (12)
References (8)
  • 1
    • 33144472815 scopus 로고    scopus 로고
    • PAT Guidance for Industry: A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance
    • U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), September
    • PAT Guidance for Industry: A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), September 2004.
    • (2004)
  • 2
    • 33847701738 scopus 로고    scopus 로고
    • Guidance for Industry: Q8 Pharmaceutical Development
    • U.S. Department of Health and Human Service, Food and Drug Administration (FDA), May
    • Guidance for Industry: Q8 Pharmaceutical Development. U.S. Department of Health and Human Service, Food and Drug Administration (FDA), May 2006.
    • (2006)
  • 3
    • 33747451721 scopus 로고    scopus 로고
    • Current and future issues in the manufacturing and development of monoclonal antibodies
    • Kozlowski S, Swann P. Current and future issues in the manufacturing and development of monoclonal antibodies. Adv Drug Deliv Rev 2006;58:707-722.
    • (2006) Adv Drug Deliv Rev , vol.58 , pp. 707-722
    • Kozlowski, S.1    Swann, P.2
  • 4
    • 60149106150 scopus 로고    scopus 로고
    • Quality by Design for Pharmaceuticals: Regulatary Perspective and Approach
    • Rathore AS, Winkle H. Quality by Design for Pharmaceuticals: Regulatary Perspective and Approach. Nature Biotechnology 2009;27:26-34.
    • (2009) Nature Biotechnology , vol.27 , pp. 26-34
    • Rathore, A.S.1    Winkle, H.2
  • 6
    • 45149110911 scopus 로고    scopus 로고
    • Defining design space for biotech products: case study of Pichia pastoris fermentation
    • Harms J, Wang X, Kim T, Yang J, Rathore AS. Defining design space for biotech products: case study of Pichia pastoris fermentation. Biotechnol Prog 2008;24(3):655-662.
    • (2008) Biotechnol Prog , vol.24 , Issue.3 , pp. 655-662
    • Harms, J.1    Wang, X.2    Kim, T.3    Yang, J.4    Rathore, A.S.5
  • 7
    • 33750707888 scopus 로고    scopus 로고
    • A review of process analytical technology (PAT) in the U.S. pharmaceutical industry
    • Munson J, Stanfiled CF, Gujral B. A review of process analytical technology (PAT) in the U.S. pharmaceutical industry. Curr Pharm Anal 2006;2:405-414.
    • (2006) Curr Pharm Anal , vol.2 , pp. 405-414
    • Munson, J.1    Stanfiled, C.F.2    Gujral, B.3
  • 8
    • 44449122383 scopus 로고    scopus 로고
    • Case study and application of process analytical technology (PAT) towards bioprocessing: use of on-line high performance liquid chromatography (HPLC) for making real time pooling decisions for process chromatography
    • Rathore AS, Yu M, Yeboah S, Sharma A. Case study and application of process analytical technology (PAT) towards bioprocessing: use of on-line high performance liquid chromatography (HPLC) for making real time pooling decisions for process chromatography. Biotechnol Bioeng 2008;100:306-316.
    • (2008) Biotechnol Bioeng , vol.100 , pp. 306-316
    • Rathore, A.S.1    Yu, M.2    Yeboah, S.3    Sharma, A.4

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.