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Items: 1 to 20 of 56

1.

Meeting report on protein particles and immunogenicity of therapeutic proteins: filling in the gaps in risk evaluation and mitigation.

Carpenter J, Cherney B, Lubinecki A, Ma S, Marszal E, Mire-Sluis A, Nikolai T, Novak J, Ragheb J, Simak J.

Biologicals. 2010 Sep;38(5):602-11. doi: 10.1016/j.biologicals.2010.07.002. Epub 2010 Aug 11.

PMID:
20702108
2.

Protein particles: what we know and what we do not know.

Ripple DC, Dimitrova MN.

J Pharm Sci. 2012 Oct;101(10):3568-79. doi: 10.1002/jps.23242. Epub 2012 Jun 26. Review.

PMID:
22736521
3.

Follow-on protein products: scientific issues, developments and challenges.

Rathore AS.

Trends Biotechnol. 2009 Dec;27(12):698-705. doi: 10.1016/j.tibtech.2009.09.004. Epub 2009 Oct 19. Review.

PMID:
19846228
4.

How to systematically evaluate immunogenicity of therapeutic proteins - regulatory considerations.

Jahn EM, Schneider CK.

N Biotechnol. 2009 Jun;25(5):280-6. doi: 10.1016/j.nbt.2009.03.012. Epub 2009 Apr 5. Review.

PMID:
19491045
5.

Analytical techniques for the evaluation of liquid protein therapeutics.

Tatford OC, Gomme PT, Bertolini J.

Biotechnol Appl Biochem. 2004 Aug;40(Pt 1):67-81. Review.

PMID:
15270709
6.

Detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals.

Wadhwa M, Gaines-Das R, Thorpe R, Mire-Sluis A.

Dev Biol (Basel). 2005;122:155-70. Review.

PMID:
16375260
7.

Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.

Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, Barrett YC, Devanarayan V, Gorovits B, Gupta S, Parish T, Quarmby V, Moxness M, Swanson SJ, Taniguchi G, Zuckerman LA, Stebbins CC, Mire-Sluis A.

J Immunol Methods. 2008 Apr 20;333(1-2):1-9. doi: 10.1016/j.jim.2008.01.001. Epub 2008 Jan 29. Review.

PMID:
18275969
8.

An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics.

Singh SK, Afonina N, Awwad M, Bechtold-Peters K, Blue JT, Chou D, Cromwell M, Krause HJ, Mahler HC, Meyer BK, Narhi L, Nesta DP, Spitznagel T.

J Pharm Sci. 2010 Aug;99(8):3302-21. doi: 10.1002/jps.22097. Review.

PMID:
20310025
9.

Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials.

EFSA GMO Panel Working Group on Animal Feeding Trials.

Food Chem Toxicol. 2008 Mar;46 Suppl 1:S2-70. doi: 10.1016/j.fct.2008.02.008. Epub 2008 Feb 13. Review.

PMID:
18328408
10.

A review of the in vivo and in vitro toxicity of silver and gold particulates: particle attributes and biological mechanisms responsible for the observed toxicity.

Johnston HJ, Hutchison G, Christensen FM, Peters S, Hankin S, Stone V.

Crit Rev Toxicol. 2010 Apr;40(4):328-46. doi: 10.3109/10408440903453074. Review.

PMID:
20128631
11.

Risk reduction in biotherapeutic products.

Ill CR, Dehghani H.

Curr Opin Drug Discov Devel. 2009 Mar;12(2):296-304. Review.

PMID:
19333875
12.

Alternative strategies in drug development: clinical pharmacological aspects.

Kuhlmann J.

Int J Clin Pharmacol Ther. 1999 Dec;37(12):575-83. Review.

PMID:
10599949
13.

Protein particulate detection issues in biotherapeutics development--current status.

Das TK.

AAPS PharmSciTech. 2012 Jun;13(2):732-46. doi: 10.1208/s12249-012-9793-4. Epub 2012 May 8. Review.

14.

Biosimilars: current status and future directions.

Roger SD.

Expert Opin Biol Ther. 2010 Jul;10(7):1011-8. doi: 10.1517/14712591003796553. Review.

PMID:
20384525
15.

[Development of antituberculous drugs: current status and future prospects].

Tomioka H, Namba K.

Kekkaku. 2006 Dec;81(12):753-74. Review. Japanese.

PMID:
17240921
16.

A critical review of analytical methods for subvisible and visible particles.

Narhi LO, Jiang Y, Cao S, Benedek K, Shnek D.

Curr Pharm Biotechnol. 2009 Jun;10(4):373-81. Review.

PMID:
19519412
17.

Immunogenicity of biotherapeutics in the context of developing biosimilars and biobetters.

Barbosa MD.

Drug Discov Today. 2011 Apr;16(7-8):345-53. doi: 10.1016/j.drudis.2011.01.011. Epub 2011 Feb 12. Review.

PMID:
21300174
18.

Progress and dilemma of contemporary clinical pharmacology.

Herman ZS.

Int J Clin Pharmacol Ther. 2005 Jan;43(1):43-50. Review.

PMID:
15704614
19.

WHO working group on standardisation and control of acellular pertussis vaccines--report of a meeting held on 16-17 March 2006, St. Albans, United Kingdom.

Xing DK, Corbel MJ, Dobbelaer R, Knezevic I.

Vaccine. 2007 Apr 12;25(15):2749-57. Epub 2006 Sep 29.

PMID:
17368348
20.

Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals.

Wadhwa M, Bird C, Dilger P, Gaines-Das R, Thorpe R.

J Immunol Methods. 2003 Jul;278(1-2):1-17. Review.

PMID:
12957392

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