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European Journal of Pharmaceutics and Biopharmaceutics

Volumn 85, Issue 3 PART B, 2013, Pages 1084-1087

Pharmaceutical feasibility of sub-visible particle analysis in parenterals with reduced volume light obscuration methods

(8) Hawe, Andrea a Schaubhut, Frank a Geidobler, Raimund a Wiggenhorn, Michael a Friess, Wolfgang b Rast, Markus c De Muynck, Christian c Winter, Gerhard b

a Biopharmaceutical Research and Development ^* (Germany)

b UNIVERSITY OF MUNICH (Germany)

c Nycomed: A Takeda Company (Germany)

Author keywords

Aggregation; Light obscuration; Parenterals; Protein formulation; Quality control; Sub visible particles

Indexed keywords

IMMUNOGLOBULIN G1; POLYSTYRENE;

COMPARATIVE STUDY; FEASIBILITY STUDY; HUMAN; LIGHT OBSCURATION; LIGHT RELATED PHENOMENA; MEASUREMENT PRECISION; PARTICULATE MATTER; REVIEW;

AGGREGATION; LIGHT OBSCURATION; PARENTERALS; PROTEIN FORMULATION; QUALITY CONTROL; SUB-VISIBLE PARTICLES;

2-PYRIDINYLMETHYLSULFINYLBENZIMIDAZOLES; ANIMALS; CATTLE; CHEMISTRY, PHARMACEUTICAL; DRUG CONTAMINATION; FEASIBILITY STUDIES; HUMANS; IMMUNOGLOBULIN G; INFUSIONS, PARENTERAL; LIGHT; PARTICLE SIZE; PHARMACEUTICAL SOLUTIONS; POLYSTYRENES; PROTEINS; REPRODUCIBILITY OF RESULTS; SERUM ALBUMIN, BOVINE; TECHNOLOGY, PHARMACEUTICAL;

EID: 84889088785 PISSN: 09396411 EISSN: 18733441 Source Type: Journal
DOI: 10.1016/j.ejpb.2013.02.004 Document Type: Article

Times cited : (13)

References (8)

1
- 85032450717
- General, particulate contamination: Sub-visible particles
- Ph. Eur. seventh ed. (Chapter 2.9.19)
- Ph. Eur., General, particulate contamination: sub-visible particles, in: The European Pharmacopoiea, seventh ed., 2011 (Chapter 2.9.19).
- (2011) The European Pharmacopoiea

2
- 84889085002
- USP, 〈788〉 Particulate Matters in Injections, The United States Pharmacopoia - National Formulary, USP 29-NF, 2006
- USP, 〈788〉 Particulate Matters in Injections, The United States Pharmacopoia - National Formulary, USP 29-NF, 2006.

3
- 77950353318
- Sub-visible particle quantitation in protein therapeutics
- S. Cao, N. Jiao, Y. Jiang, A. Mire-Sluis, and L.O. Narhi Sub-visible particle quantitation in protein therapeutics Pharmeur Bio Sci Notes 2009 2009 73 79
- (2009) Pharmeur Bio Sci Notes , vol.2009 , pp. 73-79
- Cao, S.¹ Jiao, N.² Jiang, Y.³ Mire-Sluis, A.⁴ Narhi, L.O.⁵

4
- 78649673766
- A light-obscuration method specific for quantifying subvisible particles in protein therapeutics
- S.J. Cao, and Y.L. Narhi A light-obscuration method specific for quantifying subvisible particles in protein therapeutics Phoarmacopeial Forum 36 2010 824 834
- (2010) Phoarmacopeial Forum , vol.36 , pp. 824-834
- Cao, S.J.¹ Narhi, Y.L.²

5
- 62749099087
- Overlooking subvisible particles in therapeutic protein products: Gaps that may compromise product quality
- J.F. Carpenter, T.W. Randolph, W. Jiskoot, D.J. Crommelin, C.R. Middaugh, G. Winter, Y.X. Fan, S. Kirshner, D. Verthelyi, S. Kozlowski, K.A. Clouse, P.G. Swann, A. Rosenberg, and B. Cherney Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality J. Pharm. Sci. 98 2009 1201 1205
- (2009) J. Pharm. Sci. , vol.98 , pp. 1201-1205
- Carpenter, J.F.¹ Randolph, T.W.² Jiskoot, W.³ Crommelin, D.J.⁴ Middaugh, C.R.⁵ Winter, G.⁶ Fan, Y.X.⁷ Kirshner, S.⁸ Verthelyi, D.⁹ Kozlowski, S.¹⁰ Clouse, K.A.¹¹ Swann, P.G.¹² Rosenberg, A.¹³ Cherney, B.¹⁴

6
- 84889079185
- An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics
- S.K. Singh, N. Afonina, M. Awwad, K. Bechtold-Peters, J.T. Blue, D. Chou, M. Cromwell, H.J. Krause, H.C. Mahler, B.K. Meyer, L. Narhi, D.P. Nesta, and T. Spitznagel An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics J. Pharm. Sci. 2011
- (2011) J. Pharm. Sci.
- Singh, S.K.¹ Afonina, N.² Awwad, M.³ Bechtold-Peters, K.⁴ Blue, J.T.⁵ Chou, D.⁶ Cromwell, M.⁷ Krause, H.J.⁸ Mahler, H.C.⁹ Meyer, B.K.¹⁰ Narhi, L.¹¹ Nesta, D.P.¹² Spitznagel, T.¹³

7
- 84943546764
- 〈787〉 Subvisible particulate matter in therapeutic protein injections - New proposed chapter
- USP 〈787〉 Subvisible particulate matter in therapeutic protein injections - new proposed chapter Pharmacopieal Forum 38 2012
- (2012) Pharmacopieal Forum , vol.38

8
- 84886137952
- Analytical methods to measure subvisible particulates
- H.C. Mahler, W. Jiskoot, Wiley Hoboken, New Jersey
- S. Cao, L. Narhi, Y. Jiang, and R.S. Rajan Analytical methods to measure subvisible particulates H.C. Mahler, W. Jiskoot, Analysis of Aggregates and Particulates in Protein Pharmaceuticals 2012 Wiley Hoboken, New Jersey
- (2012) Analysis of Aggregates and Particulates in Protein Pharmaceuticals
- Cao, S.¹ Narhi, L.² Jiang, Y.³ Rajan, R.S.⁴

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.