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Volumn , Issue , 2007, Pages 433-442

Product Characterization from Gene to Therapeutic Product

Author keywords

Characterization data for recombinant therapeutics; Physicochemical characterization; Product characterization; Product stability testing; Stability analysis

Indexed keywords


EID: 84889432496     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470723791.ch22     Document Type: Chapter
Times cited : (4)

References (11)
  • 2
    • 0034997401 scopus 로고    scopus 로고
    • Br. J. Cancer
    • Egrie JC, Browne JK (2001) Br. J. Cancer; 84(Supp1): 3-10.
    • (2001) , vol.84 , pp. 3-10
    • Egrie, J.C.1    Browne, J.K.2
  • 3
    • 84889313893 scopus 로고    scopus 로고
    • Final Rule on 21 CFR Parts 314 and 601: 'Postmarketing Studies for Approved Human Drug and Licensed Biological Products
    • Food and Drug Administration (FDA), Department of Health and Human Services, FDA; 27 February, Federal Register, October 30, 2000/Rules and Regulations
    • Food and Drug Administration (FDA) Final Rule on 21 CFR Parts 314 and 601: 'Postmarketing Studies for Approved Human Drug and Licensed Biological Products'; Department of Health and Human Services, FDA; 27 February 2001) Federal Register, Vol. 65, No 210, October 30, 2000/Rules and Regulations.
    • (2001) , vol.65 , Issue.210
  • 4
    • 84889391125 scopus 로고    scopus 로고
    • ICH Steering Committee (10 March 1999) ICH Harmonized Tripartite Guideline Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
    • ICH Steering Committee (10 March 1999) ICH Harmonized Tripartite Guideline Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.
  • 5
    • 84889375975 scopus 로고    scopus 로고
    • Encyclopedia of Bioprocess Technology
    • Eds Flickinger MC, Drew SW John Wiley & Sons, Inc. New York
    • James DC, Baker KN (1999) In Encyclopedia of Bioprocess Technology. Eds Flickinger MC, Drew SW John Wiley & Sons, Inc. New York; 1336-1349.
    • (1999) , pp. 1336-1349
    • James, D.C.1    Baker, K.N.2
  • 8
    • 0043208919 scopus 로고    scopus 로고
    • Nature Biotechnol
    • Walsh G (2003) Nature Biotechnol.; 21: 865-870.
    • (2003) , vol.21 , pp. 865-870
    • Walsh, G.1
  • 9
    • 8544272747 scopus 로고    scopus 로고
    • Eur. J. Par. Sci
    • Wright JF (1997) Eur. J. Par. Sci.; 2(4): 103-108.
    • (1997) , vol.2 , Issue.4 , pp. 103-108
    • Wright, J.F.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.