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Items: 1 to 20 of 130

1.

Immunotoxicology IV - innovative methods and applications for risk assessment in pharmaceutical development: introduction to the conference.

House RV.

J Immunotoxicol. 2008 Jan;5(1):1. doi: 10.1080/15476910801897300. No abstract available.

PMID:
18382851
2.

Hazard identification and risk assessment for biologics targeting the immune system.

Weir AB.

J Immunotoxicol. 2008 Jan;5(1):3-10. doi: 10.1080/15476910801897409. Review.

PMID:
18382852
3.

Practical approaches to dose selection for first-in-human clinical trials with novel biopharmaceuticals.

Tibbitts J, Cavagnaro JA, Haller CA, Marafino B, Andrews PA, Sullivan JT.

Regul Toxicol Pharmacol. 2010 Nov;58(2):243-51. doi: 10.1016/j.yrtph.2010.06.007. Epub 2010 Jun 15.

PMID:
20558225
4.

[Anemia and immunotherapy].

Dorval T.

Bull Cancer. 2003 Apr;90 Spec No:S158-60. Review. French.

PMID:
12856428
5.

Testing human biologicals in animal host resistance models.

Burleson GR, Burleson FG.

J Immunotoxicol. 2008 Jan;5(1):23-31. doi: 10.1080/15476910801897557. Review.

PMID:
18382855
6.

Novel biomarkers of acute kidney toxicity.

Goodsaid FM, Blank M, Dieterle F, Harlow P, Hausner E, Sistare F, Thompson A, Vonderscher J.

Clin Pharmacol Ther. 2009 Nov;86(5):490-6. doi: 10.1038/clpt.2009.149. Epub 2009 Aug 26.

PMID:
19710639
7.

New challenges and opportunities in nonclinical safety testing of biologics.

Baumann A, Flagella K, Forster R, de Haan L, Kronenberg S, Locher M, Richter WF, Theil FP, Todd M.

Regul Toxicol Pharmacol. 2014 Jul;69(2):226-33. doi: 10.1016/j.yrtph.2014.04.005. Epub 2014 Apr 19.

PMID:
24755365
8.

Adverse consequences of immunostimulation.

Ponce R.

J Immunotoxicol. 2008 Jan;5(1):33-41. doi: 10.1080/15476910801897920.

PMID:
18382856
9.

[Relatively good safety in Swedish phase I trials. A survey of studies reported to the Medical Products Agency during 3 years].

Glazer A, Hedenmalm K.

Lakartidningen. 2008 Sep 10-16;105(37):2482-4. Swedish. No abstract available.

PMID:
19006863
10.

Adverse side-effects to biological agents.

Pichler WJ.

Allergy. 2006 Aug;61(8):912-20. Review.

11.

Monoclonal antibodies as innovative therapeutics.

Reichert JM.

Curr Pharm Biotechnol. 2008 Dec;9(6):423-30. Review.

PMID:
19075682
12.

[Acute side effects of the therapeutic use of biologics . How and why?].

Homey B.

Hautarzt. 2008 May;59(5):438. German. No abstract available.

PMID:
18777641
13.

Preclinical development of monoclonal antibodies: considerations for the use of non-human primates.

Chapman K, Pullen N, Coney L, Dempster M, Andrews L, Bajramovic J, Baldrick P, Buckley L, Jacobs A, Hale G, Green C, Ragan I, Robinson V.

MAbs. 2009 Sep-Oct;1(5):505-16. Epub 2009 Sep 30.

14.

Summary of a workshop on nonclinical and clinical immunotoxicity assessment of immunomodulatory drugs.

Piccotti JR, Lebrec HN, Evans E, Herzyk DJ, Hastings KL, Burns-Naas LA, Gourley IS, Wierda D, Kawabata TT.

J Immunotoxicol. 2009 Mar;6(1):1-10. doi: 10.1080/15476910802656440.

PMID:
19519157
15.

Applying physiological and biochemical concepts to optimize biological drug development.

Lowe PJ.

Clin Pharmacol Ther. 2010 Apr;87(4):492-6. doi: 10.1038/clpt.2009.302. Epub 2010 Feb 10.

PMID:
20147897
16.

Dealing with immunogenicity of biologicals: assessment and clinical relevance.

Wolbink GJ, Aarden LA, Dijkmans BA.

Curr Opin Rheumatol. 2009 May;21(3):211-5. Review.

PMID:
19399992
17.

Comparative overview of safety of the biologics in rheumatoid arthritis.

Khraishi M.

J Rheumatol Suppl. 2009 Jun;82:25-32. doi: 10.3899/jrheum.090128. Review.

PMID:
19509327
18.

Phase I/II open-label study of the biologic effects of the interleukin-2 immunocytokine EMD 273063 (hu14.18-IL2) in patients with metastatic malignant melanoma.

Ribas A, Kirkwood JM, Atkins MB, Whiteside TL, Gooding W, Kovar A, Gillies SD, Kashala O, Morse MA.

J Transl Med. 2009 Jul 29;7:68. doi: 10.1186/1479-5876-7-68.

19.

Immunogenicity: prediction, detection and effective assay development.

Gorovits B.

Bioanalysis. 2010 Sep;2(9):1539-45. doi: 10.4155/bio.10.121. No abstract available.

20.

Research and development of biological products in China.

Zhu J.

Chin Med J (Engl). 1995 Jul;108(7):490-2. No abstract available.

PMID:
7555264

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