Direct-acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: Scientific and regulatory approaches to clinical trial designs

Hepatology

Volumn 62, Issue 4, 2015, Pages 1298-1303

  Mishra, Poonam ^a   Murray, Jeffrey ^a   Birnkrant, Debra ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVIRUS AGENT; PEGINTERFERON; RIBAVIRIN;

ARTICLE; CHRONIC HEPATITIS C; CONTROLLED CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT DURATION; TREATMENT INDICATION; TREATMENT RESPONSE; CLINICAL TRIAL (TOPIC); FORECASTING; HEPATITIS C, CHRONIC; METHODOLOGY; PROCEDURES; STANDARDS; TRENDS; UNITED STATES;

ANTIVIRAL AGENTS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; FORECASTING; HEPATITIS C, CHRONIC; HUMANS; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84942552026     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.27880     Document Type: Article

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