Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes

Therapeutic Innovation and Regulatory Science

Volumn 49, Issue 1, 2015, Pages 50-64

  Geiger, Mary Jane ^a   Mehta, Cyrus ^b   Turner, J Rick ^c   Arbet Engels, Christophe ^d   Hantel, Stefan ^e   Hirshberg, Boaz ^f   Koglin, Joerg ^g   Mendzelevski, Boaz ^h   Sager, Philip T ⁱ   Shapiro, Deborah ^g   Stewart, Murray ^j   Todaro, Thomas G ^k   Gaydos, Brenda ^l  

^a REGENERON PHARMACEUTICALS INC   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c IQVIA   (United States)

^d BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^e BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^f ASTRAZENECA   (United Kingdom)

^g MERCK RESEARCH LABORATORIES   (United States)

^h BioClinica Inc   (United States)

ⁱ STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^j GLAXOSMITHKLINE   (United States)

^k Medpace ^*  (United States)

^l ELI LILLY AND COMPANY   (United States)

more..

Author keywords

cardiovascular safety; diabetes; major adverse cardiovascular event; meta analysis; outcome trial

Indexed keywords

ANTIDIABETIC AGENT;

ARTICLE; CARDIOVASCULAR RISK; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HIGH RISK POPULATION; INCIDENCE; METHODOLOGY; NON INSULIN DEPENDENT DIABETES MELLITUS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK ASSESSMENT; STATISTICAL ANALYSIS;

EID: 84920964630     PISSN: 21684790     EISSN: 21684804     Source Type: Journal    
DOI: 10.1177/2168479014549860     Document Type: Article

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