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Volumn 35, Issue 1, 2013, Pages 38-45

Validation of an automated chromogenic assay of potency of factor VIII in commercial concentrates

Author keywords

Automated bioassay; Chromogenic assay; Factor VIII potency; Validation

Indexed keywords

BLOOD CLOTTING FACTOR 8;

EID: 84872271401     PISSN: 17515521     EISSN: 1751553X     Source Type: Journal    
DOI: 10.1111/j.1751-553X.2012.01459.x     Document Type: Article
Times cited : (6)

References (21)
  • 1
    • 0347504791 scopus 로고    scopus 로고
    • Blood coagulation factor VIII: an overview
    • Bhopale GM, Nanda RK. Blood coagulation factor VIII: an overview. J Biosci 2003;28:783-9.
    • (2003) J Biosci , vol.28 , pp. 783-789
    • Bhopale, G.M.1    Nanda, R.K.2
  • 2
    • 0032402122 scopus 로고    scopus 로고
    • The life cycle of coagulation factor VIII in view of its structure and Function
    • Lenting PJ, van Mourik JA, Mertens K. The life cycle of coagulation factor VIII in view of its structure and Function. Blood 1998;92:3983-96.
    • (1998) Blood , vol.92 , pp. 3983-3996
    • Lenting, P.J.1    van Mourik, J.A.2    Mertens, K.3
  • 3
    • 0038362149 scopus 로고    scopus 로고
    • Coagulation factor VIII: structure and stability
    • Wang W, Wang YJ, Kelner DN. Coagulation factor VIII: structure and stability. Int J Pharm 2003;259:1-15.
    • (2003) Int J Pharm , vol.259 , pp. 1-15
    • Wang, W.1    Wang, Y.J.2    Kelner, D.N.3
  • 4
    • 0021248074 scopus 로고
    • Assay of factor VIII: C with a chromogenic substrate
    • Rosén S. Assay of factor VIII: C with a chromogenic substrate. Scand J Haematol 1984;33(Suppl.40):139-45.
    • (1984) Scand J Haematol , vol.33 , Issue.SUPPL. 40 , pp. 139-145
    • Rosén, S.1
  • 5
    • 0032877592 scopus 로고    scopus 로고
    • Determination of coagulation factor VIII activity by a chromogenic substrate method on STA, an automated coagulation analyzer
    • Kleinveld HA, Andersson N-E, van Voorthuizen H, den Hartog J, de Groot PG. Determination of coagulation factor VIII activity by a chromogenic substrate method on STA, an automated coagulation analyzer. Scand J Clin Lab Invest 1999;59:335-42.
    • (1999) Scand J Clin Lab Invest , vol.59 , pp. 335-342
    • Kleinveld, H.A.1    Andersson, N.-E.2    van Voorthuizen, H.3    den Hartog, J.4    de Groot, P.G.5
  • 6
    • 0006738505 scopus 로고
    • A new chromogenic factor VIII:C assay based on a system of human proteins
    • Lang H, Oberreither M, Moritz B. A new chromogenic factor VIII:C assay based on a system of human proteins. Thromb Haemost 1991;65: abstract 943.
    • (1991) Thromb Haemost , vol.65 , pp. 943
    • Lang, H.1    Oberreither, M.2    Moritz, B.3
  • 8
    • 0024403673 scopus 로고
    • Development of a simple chromogenic factor VIII assay for clinical use
    • Wagenvoord RJ, Hendrix HH, Hemker HC. Development of a simple chromogenic factor VIII assay for clinical use. Haemostasis 1989;19:196-204.
    • (1989) Haemostasis , vol.19 , pp. 196-204
    • Wagenvoord, R.J.1    Hendrix, H.H.2    Hemker, H.C.3
  • 9
    • 0027918270 scopus 로고
    • Recommendations for the assay of high-purity factor VIII concentrates
    • Barrowcliffe TW. Recommendations for the assay of high-purity factor VIII concentrates. Thromb Haemost 1993;70:876-7.
    • (1993) Thromb Haemost , vol.70 , pp. 876-877
    • Barrowcliffe, T.W.1
  • 11
    • 0036617254 scopus 로고    scopus 로고
    • Calibration of the Ph. Eur. BRP batch3 /Mega 2 (US/FDA) standard for human coagulation factor VIII concentrate for use in the potency assay
    • Kirschbaum N, Wood L, Lachenbruch P, Weinstein M, Daas A, Rautmann G, Spieser JM, Buchheit KH. Calibration of the Ph. Eur. BRP batch3 /Mega 2 (US/FDA) standard for human coagulation factor VIII concentrate for use in the potency assay. Pharmeur Bio 2002;1:31-60.
    • (2002) Pharmeur Bio , vol.1 , pp. 31-60
    • Kirschbaum, N.1    Wood, L.2    Lachenbruch, P.3    Weinstein, M.4    Daas, A.5    Rautmann, G.6    Spieser, J.M.7    Buchheit, K.H.8
  • 12
    • 79952474731 scopus 로고    scopus 로고
    • Calibration of human coagulation factor VIII concentrate Ph. Eur. BRP Batch 4 for use in potency assays
    • Raut S, Costanzo A, Daniels S, Health A, Buchheit KH. Calibration of human coagulation factor VIII concentrate Ph. Eur. BRP Batch 4 for use in potency assays. Pharmeur Bio Sci Notes 2010;2:1-29.
    • (2010) Pharmeur Bio Sci Notes , vol.2 , pp. 1-29
    • Raut, S.1    Costanzo, A.2    Daniels, S.3    Health, A.4    Buchheit, K.H.5
  • 13
    • 79959505463 scopus 로고    scopus 로고
    • International comparative field study of N8 evaluating factor VIII assay performance
    • Viuff D, Barrowcliffe TW, Saugstrup T, Ezban M, Lillicrap D. International comparative field study of N8 evaluating factor VIII assay performance. Haemophilia 2011;17:695-702.
    • (2011) Haemophilia , vol.17 , pp. 695-702
    • Viuff, D.1    Barrowcliffe, T.W.2    Saugstrup, T.3    Ezban, M.4    Lillicrap, D.5
  • 15
    • 2442456960 scopus 로고    scopus 로고
    • Variability in factor VIII concentrate measurement: results from SSC field collaborative studies
    • Raut S, Sands D, Heath AB, Barrowcliffe W. Variability in factor VIII concentrate measurement: results from SSC field collaborative studies. J Thromb Haemost 2003;1:1927-34.
    • (2003) J Thromb Haemost , vol.1 , pp. 1927-1934
    • Raut, S.1    Sands, D.2    Heath, A.B.3    Barrowcliffe, W.4
  • 18
    • 84872275947 scopus 로고
    • ICH. ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva;
    • ICH. ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva; 1995.
    • (1995)
  • 21
    • 84872263020 scopus 로고    scopus 로고
    • Chromogenic assay of human coagulation factor VIII: statistical comparison of 2 working dilution procedures
    • Alonso C, González A, Frutos G. Chromogenic assay of human coagulation factor VIII: statistical comparison of 2 working dilution procedures. Pharmeur Sci Notes 2005;1:33-40.
    • (2005) Pharmeur Sci Notes , vol.1 , pp. 33-40
    • Alonso, C.1    González, A.2    Frutos, G.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.