Antibody Drug Conjugates: Nonclinical Safety Considerations

AAPS Journal

Volumn 17, Issue 5, 2015, Pages 1055-1064

  Hinrichs, Mary Jane Masson ^a   Dixit, Rakesh ^a  

^a MEDIMMUNE   (United States)

Author keywords

antibody drug conjugates; regulatory guidance; safety assessment; therapeutic index

Indexed keywords

AGS 16M 8F; AGS 5ME; ANTIBODY CONJUGATE; ANTIBODY DRUG CONJUGATE; AVE 9633; BIVATUZUMAB MERTANSINE; BRENTUXIMAB VEDOTIN; BT 062; CALICHEAMICIN; CANTUZUMAB RAVTANSINE; CATHEPSIN B; CD44V6 ANTIGEN; COLTUXIMAB RAVTANSINE; DCDT 2980S; FC RECEPTOR; GEMTUZUMAB OZOGAMICIN; GLEMBATUMUMAB VEDOTIN; IMGN 388; INOTUZUMAB OZOGAMICIN; LORVOTUZUMAB MERTANSINE; MANNOSE RECEPTOR; MAYTANSINE; MONOMETHYL AURISTATIN PHENYLALANINE; PSMA ANTIBODY DRUG CONJUGATE; TRASTUZUMAB EMTANSINE; UNCLASSIFIED DRUG; VEDOTIN; VORSETUZUMAB MAFODOTIN; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

APOPTOSIS; ARTICLE; BIOCHEMISTRY; CELL KILLING; CELL MIGRATION; CONFUSION; DECISION MAKING; DESQUAMATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG CONJUGATION; DRUG CROSS REACTIVITY; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG SAFETY; DRUG SELECTIVITY; DRUG STABILITY; EPITHELIUM CELL; EYE TOXICITY; FATIGUE; GASTROINTESTINAL TOXICITY; GOOD LABORATORY PRACTICE; HAND FOOT SYNDROME; HEADACHE; HUMAN; HYPERTRANSAMINASEMIA; IMMUNOHISTOCHEMISTRY; IN VITRO STUDY; IN VIVO STUDY; INTERNALIZATION; KERATINOCYTE; KERATITIS; LIVER TOXICITY; LYMPHOCYTOPENIA; LYSOSOME; MEGAKARYOCYTE; MUCOSA INFLAMMATION; NEUROPATHY; NEUTROPENIA; NONHUMAN; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PROTEIN CLEAVAGE; PROTEIN TARGETING; RASH; SENSORY NEUROPATHY; SKIN TOXICITY; THROMBOCYTOPENIA; TOXIC EPIDERMAL NECROLYSIS; TUMOR CELL; ANIMAL; CHEMISTRY; DRUG DESIGN; DRUG LEGISLATION; PRECLINICAL STUDY; PROCEDURES; TOXICITY TESTING;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; DRUG DESIGN; DRUG EVALUATION, PRECLINICAL; HUMANS; IMMUNOCONJUGATES; LEGISLATION, DRUG; TOXICITY TESTS;

EID: 84939563178     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-015-9790-0     Document Type: Article

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