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Items: 1 to 20 of 87

1.

Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations.

Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, Quarmby V, Richards S, Schneider CK, Subramanyam M, Swanson S, Verthelyi D, Yim S; American Association of Pharmaceutical Scientists.

AAPS J. 2014 Jul;16(4):658-73. doi: 10.1208/s12248-014-9599-2. Epub 2014 Apr 24.

2.

Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy.

Chirmule N, Jawa V, Meibohm B.

AAPS J. 2012 Jun;14(2):296-302. doi: 10.1208/s12248-012-9340-y. Epub 2012 Mar 10. Review.

3.

Immunogenicity assessment of therapeutic proteins and peptides.

Kaliyaperumal A, Jing S.

Curr Pharm Biotechnol. 2009 Jun;10(4):352-8. Review.

PMID:
19519410
4.

Taking immunogenicity assessment of therapeutic proteins to the next level.

Büttel IC, Chamberlain P, Chowers Y, Ehmann F, Greinacher A, Jefferis R, Kramer D, Kropshofer H, Lloyd P, Lubiniecki A, Krause R, Mire-Sluis A, Platts-Mills T, Ragheb JA, Reipert BM, Schellekens H, Seitz R, Stas P, Subramanyam M, Thorpe R, Trouvin JH, Weise M, Windisch J, Schneider CK.

Biologicals. 2011 Mar;39(2):100-9. doi: 10.1016/j.biologicals.2011.01.006. Epub 2011 Feb 24.

PMID:
21353596
5.

Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortium.

Rup B, Pallardy M, Sikkema D, Albert T, Allez M, Broet P, Carini C, Creeke P, Davidson J, De Vries N, Finco D, Fogdell-Hahn A, Havrdova E, Hincelin-Mery A, C Holland M, H Jensen PE, Jury EC, Kirby H, Kramer D, Lacroix-Desmazes S, Legrand J, Maggi E, Maillère B, Mariette X, Mauri C, Mikol V, Mulleman D, Oldenburg J, Paintaud G, R Pedersen C, Ruperto N, Seitz R, Spindeldreher S, Deisenhammer F; ABIRISK Consortium.

Clin Exp Immunol. 2015 Sep;181(3):385-400. doi: 10.1111/cei.12652. Epub 2015 Jul 2. Review.

6.

Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics.

Gorovits B, Wakshull E, Pillutla R, Xu Y, Manning MS, Goyal J.

J Immunol Methods. 2014 Jun;408:1-12. doi: 10.1016/j.jim.2014.05.010. Epub 2014 May 24. Review.

PMID:
24861938
7.

Development and optimization of neutralizing antibody assays to monitor clinical immunogenicity.

Civoli F, Kroenke MA, Reynhardt K, Zhuang Y, Kaliyaperumal A, Gupta S.

Bioanalysis. 2012 Nov;4(22):2725-35. doi: 10.4155/bio.12.239. Review.

PMID:
23210655
8.

Determinants of immunogenic response to protein therapeutics.

Singh SK, Cousens LP, Alvarez D, Mahajan PB.

Biologicals. 2012 Sep;40(5):364-8. doi: 10.1016/j.biologicals.2012.06.001. Epub 2012 Jul 5.

PMID:
22770604
9.

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
10.

From the bench to clinical practice: understanding the challenges and uncertainties in immunogenicity testing for biopharmaceuticals.

Gunn GR 3rd, Sealey DC, Jamali F, Meibohm B, Ghosh S, Shankar G.

Clin Exp Immunol. 2016 May;184(2):137-46. doi: 10.1111/cei.12742. Epub 2016 Jan 19. Review.

11.

Impact of product-related factors on immunogenicity of biotherapeutics.

Singh SK.

J Pharm Sci. 2011 Feb;100(2):354-87. doi: 10.1002/jps.22276. Epub 2010 Aug 25. Review.

PMID:
20740683
12.

T-cell dependent immunogenicity of protein therapeutics: Preclinical assessment and mitigation.

Jawa V, Cousens LP, Awwad M, Wakshull E, Kropshofer H, De Groot AS.

Clin Immunol. 2013 Dec;149(3):534-55. doi: 10.1016/j.clim.2013.09.006. Epub 2013 Sep 25. Review.

13.

Evaluating and Reporting the Immunogenicity Impacts for Biological Products--a Clinical Pharmacology Perspective.

Wang YM, Wang J, Hon YY, Zhou L, Fang L, Ahn HY.

AAPS J. 2016 Mar;18(2):395-403. doi: 10.1208/s12248-015-9857-y. Epub 2015 Dec 31. Review.

14.

Immunogenicity of therapeutics: a matter of efficacy and safety.

Nechansky A, Kircheis R.

Expert Opin Drug Discov. 2010 Nov;5(11):1067-79. doi: 10.1517/17460441.2010.514326. Epub 2010 Sep 1. Review.

PMID:
22827745
15.

The future of protein particle characterization and understanding its potential to diminish the immunogenicity of biopharmaceuticals: a shared perspective.

Bee JS, Goletz TJ, Ragheb JA.

J Pharm Sci. 2012 Oct;101(10):3580-5. doi: 10.1002/jps.23247. Epub 2012 Jun 26.

PMID:
22736570
16.

Immunogenicity of therapeutic proteins: influence of aggregation.

Ratanji KD, Derrick JP, Dearman RJ, Kimber I.

J Immunotoxicol. 2014 Apr-Jun;11(2):99-109. doi: 10.3109/1547691X.2013.821564. Epub 2013 Aug 6. Review.

17.

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.

Ponce R, Abad L, Amaravadi L, Gelzleichter T, Gore E, Green J, Gupta S, Herzyk D, Hurst C, Ivens IA, Kawabata T, Maier C, Mounho B, Rup B, Shankar G, Smith H, Thomas P, Wierda D.

Regul Toxicol Pharmacol. 2009 Jul;54(2):164-82. doi: 10.1016/j.yrtph.2009.03.012. Epub 2009 Apr 2.

PMID:
19345250
18.

New FDA draft guidance on immunogenicity.

Parenky A, Myler H, Amaravadi L, Bechtold-Peters K, Rosenberg A, Kirshner S, Quarmby V.

AAPS J. 2014 May;16(3):499-503. doi: 10.1208/s12248-014-9587-6. Epub 2014 Mar 29.

19.

A survey of applications of biological products for drug interference of immunogenicity assays.

Wang YM, Fang L, Zhou L, Wang J, Ahn HY.

Pharm Res. 2012 Dec;29(12):3384-92. doi: 10.1007/s11095-012-0833-2. Epub 2012 Aug 18.

PMID:
22903525
20.

Workshop on predictive science of the immunogenicity aspects of particles in biopharmaceutical products.

Marszal E, Fowler E.

J Pharm Sci. 2012 Oct;101(10):3555-9. doi: 10.1002/jps.23243. Epub 2012 Jun 26.

PMID:
22736535

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