Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics

Journal of Pharmacological and Toxicological Methods

Volumn 58, Issue 2, 2008, Pages 72-76

  Vargas, Hugo M ^a   Bass, Alan S ^b   Breidenbach, Alexander ^c   Feldman, Hal S ^d   Gintant, Gary A ^e   Harmer, Alexander R ^f   Heath, Bronagh ^g   Hoffmann, Peter ^h   Lagrutta, Armando ^b   Leishman, Derek ⁱ   McMahon, Nick ^g   Mittelstadt, Scott ^e   Polonchuk, Liudmila ^c   Pugsley, Michael K ^j   Salata, Joseph J ^b   Valentin, Jean Pierre ^f  

^a AMGEN INC   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

^c F HOFFMANN LA ROCHE LTD   (Switzerland)

^d PFIZER INC   (United States)

^e ABBOTT LABORATORIES   (United States)

^f ASTRAZENECA   (United Kingdom)

^g GLAXOSMITHKLINE   (United Kingdom)

^h NOVARTIS PHARMA AG   (Switzerland)

ⁱ ELI LILLY AND COMPANY   (United States)

^j JOHNSON AND JOHNSON   (United States)

more..

Author keywords

Biologicals; Biopharmaceuticals; Cardiac repolarization; Cardiovascular safety; hERG potassium channel; Monoclonal antibodies; QTc prolongation; Safety pharmacology

Indexed keywords

ANTIARRHYTHMIC AGENT; AZIMILIDE; BETA CYCLODEXTRIN DERIVATIVE; BIOLOGICAL AGENT; BIOMATERIAL; CYTOKINE; DEPSIPEPTIDE; ENZYME; GROWTH FACTOR; HYBRID PROTEIN; HYDROXYLPROPYL BETA CYCLODEXTRAN; MONOCLONAL ANTIBODY; PEPTIDE ALPHA KTX20.1; PEPTIDE OSK 1; PHRIXOTOXIN; PLASMINOGEN ACTIVATOR; POTASSIUM CHANNEL BLOCKING AGENT; POTASSIUM CHANNEL HERG; RECOMBINANT PROTEIN; ROMIDEPSIN; SAXITOXIN; SMALL INTERFERING RNA; UNCLASSIFIED DRUG;

ARTICLE; BIOINFORMATICS; BIOLOGICAL THERAPY; CARDIOVASCULAR RISK; COMPUTER MODEL; DOG; DRUG DESIGN; DRUG SAFETY; EXCIPIENT COMPATIBILITY; HEART MUSCLE NECROSIS; HEART RATE; HEART REPOLARIZATION; HUMAN; ICH S6 GUIDELINE; ICH S7A GUIDELINE; ICH S7B GUIDELINE; IN VITRO STUDY; LAW; MEMBRANE BINDING; MONKEY; NONHUMAN; PERIPHERAL T CELL LYMPHOMA; PLASMA FACTOR; PRACTICE GUIDELINE; PROTEIN DOMAIN; QT PROLONGATION; REPEATED DRUG DOSE; SIDE EFFECT; STANDARDIZATION; TORSADE DES POINTES;

BIOLOGICAL PRODUCTS; CARDIOVASCULAR DISEASES; DRUG EVALUATION, PRECLINICAL; HUMANS;

RODENTIA;

EID: 48149092512     PISSN: 10568719     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vascn.2008.04.001     Document Type: Article

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