Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology

Regulatory Toxicology and Pharmacology

Volumn 67, Issue 3, 2013, Pages 382-391

  Roberts, Stanley A ^a   Andrews, Paul A ^b   Blanset, Diann ^c   Flagella, Kelly M ^d   Gorovits, Boris ^e   Lynch, Carmel M ^f   Martin, Pauline L ^g   Kramer Stickland, Kimberly ^h   Thibault, Stephane ^e   Warner, Garvin ⁱ  

^a SAR Safety Assessment   (United States)

^b EISAI INC   (United States)

^c BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^d GENENTECH INC   (United States)

^e PFIZER INC   (United States)

^f SEATTLE GENETICS INC   (United States)

^g API Large Molecule Pharmaceutical Development and Manufacturing Sciences   (United States)

^h EPIZYME INC   (United States)

ⁱ ALNYLAM PHARMACEUTICALS   (United States)

Author keywords

Antibody drug conjugates; Biotherapeutics; Cytotoxin; Linker; Payload; Regulatory toxicology; Safety assessment

Indexed keywords

CYTOTOXIC AGENT; CYTOTOXIN; MONOCLONAL ANTIBODY;

ADVANCED CANCER; ANTIGEN BINDING; ANTINEOPLASTIC ACTIVITY; ARTICLE; BINDING AFFINITY; CARCINOGENICITY; CROSS REACTION; DEVELOPMENTAL TOXICITY; DRUG CONJUGATION; DRUG CYTOTOXICITY; DRUG DESIGN; DRUG FORMULATION; DRUG SAFETY; DRUG TRANSFORMATION; GENOTOXICITY; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; IMMUNOMODULATION; NONHUMAN; PRIORITY JOURNAL; REPRODUCTIVE TOXICITY; TERATOGENICITY; TOXICITY TESTING; TOXICOKINETICS;

ANIMALIA;

ABSORPTION, DISTRIBUTION, METABOLISM AND ELIMINATION; ADC; ADME; ANTIBODY DRUG CONJUGATES; ANTIBODY-DRUG CONJUGATE; BIOTHERAPEUTICS; CYTOTOXIN; EFD; ELISA; EMBRYOFETAL DEVELOPMENT; ENZYME-LINKED IMMUNOSORBENT ASSAY; FIH; FIRST-IN-HUMAN; GLP; GOOD LABORATORY PRACTICE; HERG; HIGHEST NON-SEVERELY TOXIC DOSE IN NON-RODENT SPECIES; HNSTD; HUMAN ETHER-À-GO-GO RELATED GENE; ICH; INTERNATIONAL CONFERENCE ON HARMONISATION; LBA; LC/MS/MS; LIGAND BINDING ASSAY; LINKER; LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY; MASS SPECTROMETRY; MAXIMUM TOLERATED DOSE; MS; MTD; PAYLOAD; PD; PHARMACODYNAMICS; PHARMACOKINETICS; PK; REGULATORY TOXICOLOGY; SAFETY ASSESSMENT; SEVERELY TOXIC DOSE IN 10% OF RODENTS; STD(10); TCR; TISSUE CROSS-REACTIVITY; TK; TOXICOKINETICS; V(D); VOLUME OF DISTRIBUTION;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; DRUG DESIGN; DRUG EVALUATION, PRECLINICAL; GUIDELINES AS TOPIC; HUMANS; IMMUNOCONJUGATES; RESEARCH DESIGN; TOXICITY TESTS;

EID: 84887818844     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2013.08.017     Document Type: Article

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