Species selection

EBR - European Biopharmaceutical Review

Volumn , Issue SUMMER 2011, 2011, Pages

  De Haan, Lolke ^a   Henderson, Simon ^a   McFarlane, Mary ^a   Scott, Alison ^a   Shenton, Jacintha ^a  

^a MEDIMMUNE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY CD28; TGN 1412;

ANIMAL EXPERIMENT; DRUG RESEARCH; DRUG SCREENING; HUMAN; NONHUMAN; PRACTICE GUIDELINE; RISK ASSESSMENT; SAFETY; SHORT SURVEY; SPECIES IDENTIFICATION; TARGET ORGANISM;

EID: 79960356637     PISSN: 1364369X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (12)

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4. Suntharalingam G, Perry MR, Ward S, Brett SJ, Castello-Cortes A, Brunner MD and Panoskaltsis N, Cytokine storm in a Phase 1 trial of the anti- CD28 monoclonal antibody TGN1412, N Engl J Med 355: p1,018, 2006
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8. ICH S6(R1) Addendum: preclinical safety evaluation of biotechnologyderived pharmaceuticals
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12. EMEA/CHMP/SWP/28367/07 Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products