An FDA oncology analysis of antibody-drug conjugates

Regulatory Toxicology and Pharmacology

Volumn 71, Issue 3, 2015, Pages 444-452

  Saber, Haleh ^a   Leighton, John K ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Antibody drug conjugates; First in human start dose selection; Oncology drug development

Indexed keywords

BRENTUXIMAB VEDOTIN; MONOCLONAL ANTIBODY; TRASTUZUMAB EMTANSINE; ANTIBODY CONJUGATE; ANTINEOPLASTIC AGENT;

ALGORITHM; ANTINEOPLASTIC ACTIVITY; ARTICLE; BLOOD TOXICITY; BODY SURFACE; BODY WEIGHT; BONE MARROW TOXICITY; DRUG APPROVAL; DRUG CONJUGATION; DRUG DESIGN; DRUG DOSE ESCALATION; DRUG FATALITY; DRUG SAFETY; DRUG STABILITY; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL TOXICITY; HUMAN; LIVER TOXICITY; LUNG TOXICITY; MACACA FASCICULARIS; NEUROTOXICITY; NONHUMAN; ONCOLOGY; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; REPRODUCTIVE TOXICITY; RODENT; SENSORY NEUROPATHY; SKIN TOXICITY; TESTIS DISEASE; UTERUS DISEASE; ANIMAL; ANIMAL MODEL; BLOOD; DOSE CALCULATION; DOSE RESPONSE; MAXIMUM TOLERATED DOSE; MOUSE; NO-OBSERVED-ADVERSE-EFFECT LEVEL; PROCEDURES; RAT; REPRODUCIBILITY; RISK ASSESSMENT; TOXICITY TESTING; UNITED STATES;

ANIMALIA; MACACA FASCICULARIS; RODENTIA;

ALGORITHMS; ANIMALS; ANTINEOPLASTIC AGENTS; BODY SURFACE AREA; BODY WEIGHT; CLINICAL TRIALS, PHASE I AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG APPROVAL; DRUG DOSAGE CALCULATIONS; DRUG STABILITY; HUMANS; IMMUNOCONJUGATES; MACACA FASCICULARIS; MAXIMUM TOLERATED DOSE; MICE; MODELS, ANIMAL; NO-OBSERVED-ADVERSE-EFFECT LEVEL; RATS; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; TOXICITY TESTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84923283790     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2015.01.014     Document Type: Article

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