A public-private consortium advances cardiac safety evaluation: Achievements of the HESI Cardiac Safety Technical Committee

Journal of Pharmacological and Toxicological Methods

Volumn 68, Issue 1, 2013, Pages 7-12

  Pierson, Jennifer B ^a   Berridge, Brian R ^b   Brooks, Marjory B ^c   Dreher, Kevin ^d   Koerner, John ^e   Schultze, A Eric ^f   Sarazan, R Dustan ^g   Valentin, Jean Pierre ^h   Vargas, Hugo M ⁱ   Pettit, Syril D ^a  

^a ILSI HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE   (United States)

^b GLAXOSMITHKLINE   (United States)

^c Cornell University ^*  (United States)

^d U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

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

^f ELI LILLY AND COMPANY   (United States)

^g Data Sciences International (DSI)   (United States)

^h ASTRAZENECA   (United Kingdom)

ⁱ AMGEN INC   (United States)

Author keywords

Animal models; Cardiac biomarkers; Cardiac repolarization; Cardiac safety; FDA; ILSI HESI; Integrated risk assessment; Stem cells

Indexed keywords

BIOLOGICAL MARKER; DOXORUBICIN; ISOPRENALINE; TROPONIN;

ADVERSE DRUG REACTION; ARTICLE; CARDIOTOXICITY; CARDIOVASCULAR DISEASE; CARDIOVASCULAR SYSTEM; DISEASE MARKER; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG SAFETY; DRUG TOXICITY; GOVERNMENT; HEART ARRHYTHMIA; HEART INJURY; HISTOPATHOLOGY; HUMAN; NONHUMAN; PRACTICE GUIDELINE; PUBLIC HEALTH; STEM CELL; WORKSHOP;

ADRS; ADVERSE DRUG REACTIONS; ANIMAL MODELS; CARDIAC BIOMARKERS; CARDIAC REPOLARIZATION; CARDIAC SAFETY; CARDIAC TROPONIN; CARDIOVASCULAR; CDER; CENTER FOR DRUG EVALUATION AND RESEARCH; CORRECTED QT INTERVAL; CTN; CV; DELAYED RECTIFIER POTASSIUM CURRENT; ECG; ELECTROCARDIOGRAM; EMA; EUROPEAN MEDICINES AGENCY; EWG; EXPERT WORKING GROUP; FDA; HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE; HERG; HESI; HUMAN ETHER-Á-GO-GO RELATED GENE; ICH; IKR; ILSI; ILSI/HESI; IND; INTEGRATED RISK ASSESSMENT; INTERNATIONAL CONFERENCE ON HARMONIZATION; INTERNATIONAL LIFE SCIENCES INSTITUTE; INVESTIGATIONAL NEW DRUG; JAPANESE PHARMACEUTICAL MANUFACTURER ASSOCIATION; JPMA; NDA; NEW DRUG APPLICATION; PREDICTIVE SAFETY TESTING CONSORTIUM; PRODACT; PROJECT FOR DATABASE CONSTRUCTION; PSTC; QTC; SC-CM; STEM CELLS; STEM-CELL DERIVED CARDIAC MYOCYTES; TDP; THOROUGH QT STUDY; TORSADES DE POINTES; TQT; UNITED STATES FOOD AND DRUG ADMINISTRATION; US FDA;

ADVISORY COMMITTEES; ANIMALS; CARDIOVASCULAR DISEASES; COMMUNICATION; DRUG DESIGN; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; INTERNATIONAL COOPERATION;

ANIMALIA;

EID: 84880043414     PISSN: 10568719     EISSN: 1873488X     Source Type: Journal    
DOI: 10.1016/j.vascn.2013.03.008     Document Type: Article

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