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Volumn 25, Issue 12, 2007, Pages 1196-1201

Impurity determinations for biotechnology-derived biopharmaceuticals and related products
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EID: 37749017427     PISSN: 15275949     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (8)

References (33)
  • 1
    • 37749005701 scopus 로고    scopus 로고
    • International Conference on Harmonization QATARR, October
    • International Conference on Harmonization QATAR(R): Impurities in New Drug Substances, October 2006.
    • (2006) Impurities in New Drug Substances
  • 2
    • 37748999863 scopus 로고    scopus 로고
    • International Conference on Harmonization ABR, June
    • International Conference on Harmonization AB(R): Impurities in New Drug Products, June 2006.
    • (2006) Impurities in New Drug Products
  • 8
    • 2042519653 scopus 로고    scopus 로고
    • S.J. Higgins and B.D. Hames, Eds, Oxford University Press, New York
    • S.J. Higgins and B.D. Hames, Eds., PostTranslational Processing, A Practical Approach (Oxford University Press, New York, 1999).
    • (1999) PostTranslational Processing, A Practical Approach
  • 11
    • 37749019938 scopus 로고    scopus 로고
    • Separation of Glycoproteins by cIEF, in Methods in Molecular Biology
    • P. Thibault and S. Honda, Eds, The Humana Press, Inc, Totowa, New Jersey
    • I.S. Krull, S. Kazmi, H. Zhong, and L.C. Santora, Separation of Glycoproteins by cIEF, in Methods in Molecular Biology, Volume 213: Capillary Electrophoresis Separation of Carbohydrates, P. Thibault and S. Honda, Eds. (The Humana Press, Inc., Totowa, New Jersey, 2002), pp. 197.
    • (2002) Capillary Electrophoresis Separation of Carbohydrates , vol.213 , pp. 197
    • Krull, I.S.1    Kazmi, S.2    Zhong, H.3    Santora, L.C.4
  • 26
    • 84905333743 scopus 로고    scopus 로고
    • ICH-Topic Q6B: Specifications: Test procedures and acceptance criteria for biotechnological/biological products (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva Switzerland, 1998).
    • ICH-Topic Q6B: Specifications: Test procedures and acceptance criteria for biotechnological/biological products (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva Switzerland, 1998).
  • 29
    • 37749027125 scopus 로고    scopus 로고
    • Position Statement on the Use of Tumorigenic Cells of Human Origin for the Production of Biological and Biotechnoogical Medicinal Products
    • 1 March, CPMP/BWP/1143
    • Position Statement on the Use of Tumorigenic Cells of Human Origin for the Production of Biological and Biotechnoogical Medicinal Products. Committee for Proprietary Medicinal Products (CPMP), 1 March 2001, CPMP/BWP/1143.
    • (2001) Committee for Proprietary Medicinal Products (CPMP)
  • 31
    • 0003672412 scopus 로고    scopus 로고
    • Sixth Edition John Wiley & Sons, Inc, New York
    • G.D. Christian. Analytical Chemistry, Sixth Edition (John Wiley & Sons, Inc., New York, 2004).
    • (2004) Analytical Chemistry
    • Christian, G.D.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.