A consistency approach for evaluation of biosimilar products

Journal of Biopharmaceutical Statistics

Volumn 23, Issue 5, 2013, Pages 1054-1066

  Tsou, Hsiao Hui ^a   Chang, Wan Jung ^a   Hwang, Wong Shian ^a   Lai, Yi Hsuan ^a  

^a NATIONAL HEALTH RESEARCH INSTITUTES   (Taiwan)

Author keywords

Biosimilars; Consistent criterion; Innovator biologic; Predictive probability function

Indexed keywords

ANTIDEPRESSANT AGENT; BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; PLACEBO; PLANT MEDICINAL PRODUCT;

ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); DEPRESSION; DRUG SCREENING; EUROPEAN MEDICINES AGENCY; EUROPEAN UNION; HUMAN; INTERNAL CONSISTENCY; INTERNATIONAL COOPERATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; SAMPLE SIZE; UNSPECIFIED SIDE EFFECT;

BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; EUROPE; GUIDELINES AS TOPIC; MODELS, STATISTICAL; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SAMPLE SIZE; THERAPEUTIC EQUIVALENCY; UNITED STATES;

EID: 84883573389     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2013.813518     Document Type: Article

References (11)

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