The concordance between nonclinical and phase I clinical cardiovascular assessment from a cross-company data sharing initiative

Toxicological Sciences

Volumn 142, Issue 2, 2014, Pages 427-435

  Ewart, Lorna ^a   Aylott, Mike ^b,c,k,l   Deurinck, Mark ^c   Engwall, Mike ^d   Gallacher, David J ^e   Geys, Helena ^e   Jarvis, Philip ^a,c,k,l   Ju, Haisong ^f   Leishman, Derek ^g   Leong, Louise ^h   McMahon, Nick ^b   Mead, Andy ⁱ   Milliken, Phil ^b   Suter, Willi ^c   Teisman, Ard ⁱ   Van Ammel, Karel ⁱ   Vargas, Hugo M ^d   Wallis, Rob ^j   Valentin, Jean Pierre ^a,c,k,l  

^a ASTRAZENECA R AND D   (Sweden)

^b GLAXOSMITHKLINE   (United Kingdom)

^c NOVARTIS PHARMA AG   (Switzerland)

^d AMGEN INC   (United States)

^e JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^f NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

^g ELI LILLY AND COMPANY   (United States)

^h ASSOCIATION OF THE BRITISH PHARMACEUTICAL INDUSTRY   (United Kingdom)

ⁱ PFIZER INC   (United States)

^j Safety Pharmacology consultant   (United Kingdom)

^k Chemin du Foriest ^*  (United Kingdom)

^l UCB PHARMA   (Belgium)

more..

Author keywords

Cardiovascular system; Concordance; Phase i; Safety pharmacology; Statistical analysis; Translational safety

Indexed keywords

ARTICLE; CARDIOVASCULAR EFFECT; CARDIOVASCULAR PARAMETERS; CLINICAL STUDY; DIASTOLIC BLOOD PRESSURE; DRUG EFFECT; HEART RATE; HUMAN; NONHUMAN; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL (TOPIC); PR INTERVAL; PREDICTIVE VALUE; PROBABILITY; QT INTERVAL; RISK ASSESSMENT; TELEMETRY; ANIMAL; BLOOD PRESSURE; CARDIOTOXICITY; DOG; DRUG EFFECTS; DRUG INDUSTRY; DRUG SCREENING; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; ELECTROCARDIOGRAPHY; NORMAL HUMAN; PATHOPHYSIOLOGY; PROCEDURES; SENSITIVITY AND SPECIFICITY; STANDARDS; STATISTICS AND NUMERICAL DATA; TRANSLATIONAL RESEARCH;

ANIMALIA; CANIS FAMILIARIS;

ANIMALS; BLOOD PRESSURE; CARDIOTOXICITY; CLINICAL TRIALS, PHASE I AS TOPIC; DOGS; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; ELECTROCARDIOGRAPHY; HEALTHY VOLUNTEERS; HEART RATE; HUMANS; PREDICTIVE VALUE OF TESTS; SENSITIVITY AND SPECIFICITY; TELEMETRY; TRANSLATIONAL MEDICAL RESEARCH;

EID: 84921737927     PISSN: 10966080     EISSN: 10960929     Source Type: Journal    
DOI: 10.1093/toxsci/kfu198     Document Type: Article

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