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Results: 1 to 20 of 317

Related Citations for PubMed (Select 18993008)

1.

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products.

Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, Fiscella M, Gorovits B, Kirschner S, Moxness M, Parish T, Quarmby V, Smith H, Smith W, Zuckerman LA, Koren E.

J Pharm Biomed Anal. 2008 Dec 15;48(5):1267-81. doi: 10.1016/j.jpba.2008.09.020. Epub 2008 Sep 19. Review.

PMID:
18993008
2.

Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products.

Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, Parish T, Scott G, Shankar G, Shores E, Swanson SJ, Taniguchi G, Wierda D, Zuckerman LA.

J Immunol Methods. 2004 Jun;289(1-2):1-16.

PMID:
15251407
3.

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
4.

Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics.

Gupta S, Indelicato SR, Jethwa V, Kawabata T, Kelley M, Mire-Sluis AR, Richards SM, Rup B, Shores E, Swanson SJ, Wakshull E.

J Immunol Methods. 2007 Apr 10;321(1-2):1-18. Epub 2007 Jan 12. Review.

PMID:
17307199
5.

Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective.

Findlay JW, Smith WC, Lee JW, Nordblom GD, Das I, DeSilva BS, Khan MN, Bowsher RR.

J Pharm Biomed Anal. 2000 Jan;21(6):1249-73.

PMID:
10708409
6.

Regulatory considerations for development of bioanalytical assays for biotechnology products.

Swann PG, Shapiro MA.

Bioanalysis. 2011 Mar;3(6):597-603. doi: 10.4155/bio.11.27.

PMID:
21417729
7.

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
8.

Scientific and regulatory considerations on the immunogenicity of biologics.

Shankar G, Shores E, Wagner C, Mire-Sluis A.

Trends Biotechnol. 2006 Jun;24(6):274-80. Epub 2006 May 2. Review.

PMID:
16631266
9.

An overview of scientific and regulatory issues for the immunogenicity of biological products.

Chamberlain P, Mire-Sluis AR.

Dev Biol (Basel). 2003;112:3-11. Review.

PMID:
12762499
10.

The challenges of immunogenicity in developing biosimilar products.

Wadhwa M, Thorpe R.

IDrugs. 2009 Jul;12(7):440-4. Review.

PMID:
19579165
12.

Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics.

Gupta S, Devanarayan V, Finco D, Gunn GR 3rd, Kirshner S, Richards S, Rup B, Song A, Subramanyam M.

J Pharm Biomed Anal. 2011 Jul 15;55(5):878-88. doi: 10.1016/j.jpba.2011.03.038. Epub 2011 Apr 6. Review.

PMID:
21531522
13.

Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies.

Geng D, Shankar G, Schantz A, Rajadhyaksha M, Davis H, Wagner C.

J Pharm Biomed Anal. 2005 Sep 15;39(3-4):364-75. Review.

PMID:
15963677
14.

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
15.

Sample size consideration for immunoassay screening cut-point determination.

Zhang J, Zhang L, Yang H.

J Biopharm Stat. 2014;24(3):535-45. doi: 10.1080/10543406.2014.889921.

PMID:
24697778
16.

Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics.

Finco D, Baltrukonis D, Clements-Egan A, Delaria K, Gunn GR 3rd, Lowe J, Maia M, Wong T.

J Pharm Biomed Anal. 2011 Jan 25;54(2):351-8. doi: 10.1016/j.jpba.2010.08.029. Epub 2010 Sep 21.

PMID:
20863644
17.

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
18.

Pharmacokinetic aspects of biotechnology products.

Tang L, Persky AM, Hochhaus G, Meibohm B.

J Pharm Sci. 2004 Sep;93(9):2184-204. Review.

PMID:
15295780
19.

A formal comparison of different methods for establishing cut points to distinguish positive and negative samples in immunoassays.

Jaki T, Lawo JP, Wolfsegger MJ, Singer J, Allacher P, Horling F.

J Pharm Biomed Anal. 2011 Jul 15;55(5):1148-56. doi: 10.1016/j.jpba.2011.04.006. Epub 2011 Apr 15.

PMID:
21561734
20.

Nonclinical development of biopharmaceuticals.

Baumann A.

Drug Discov Today. 2009 Dec;14(23-24):1112-22. doi: 10.1016/j.drudis.2009.09.013. Epub 2009 Oct 21. Review.

PMID:
19853058
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