Safety evaluation of biological drugs: What are toxicology studies in primates telling us?

Regulatory Toxicology and Pharmacology

Volumn 59, Issue 2, 2011, Pages 227-236

  Baldrick, Paul ^a  

^a UK   (United Kingdom)

Author keywords

Anti drug antibodies; Biological drugs; Monoclonal antibodies; Primate; Recombinant proteins; Repeat dose; Toxicity

Indexed keywords

IMMUNOGLOBULIN; MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ANTIBODY DETECTION; ARTICLE; BLOOD ANALYSIS; CONTROLLED STUDY; CYTOKINE RELEASE; ELECTROCARDIOGRAPHY; FEMALE; FOOD INTAKE; HEART RATE; HISTOPATHOLOGY; HYPOTENSION; IMMUNOPHENOTYPING; MALE; NONHUMAN; OPTIC DISK ANOMALY; ORGAN WEIGHT; PRIMATE; PRIORITY JOURNAL; RISK ASSESSMENT; TOXICITY TESTING; TOXICOKINETICS; URINALYSIS; WEIGHT REDUCTION;

ANIMALS; ANTIBODIES, MONOCLONAL; DRUG EVALUATION, PRECLINICAL; FEMALE; IMMUNOGLOBULINS; MACACA FASCICULARIS; MACACA MULATTA; MALE; MAXIMUM TOLERATED DOSE; MODELS, ANIMAL; RECOMBINANT PROTEINS; RESEARCH DESIGN; TOXICITY TESTS;

PRIMATES;

EID: 79952073057     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2010.10.005     Document Type: Article

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