Statistical considerations in biosimilarclinical efficacy trials withasymmetrical margins

Statistics in Medicine

Volumn 32, Issue 3, 2013, Pages 393-405

  Li, Yulan ^a   Liu, Qing ^b   Wood, Patricia ^a   Johri, Anandhi ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

^b JANSSEN RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Bioequivalence trials; Immunogenicity; Lower predictive bound; Non inferiority trials; Retention ofeffect

Indexed keywords

ANTINEOPLASTIC AGENT; BIOLOGICAL PRODUCT; BIOSIMILAR AGENT; METHOTREXATE; PLACEBO;

ADD ON THERAPY; ANEMIA; ARTICLE; BACTERIAL INFECTION; BIOSIMILARITY; CLINICAL TRIAL (TOPIC); CYTOPENIA; DRUG EFFICACY; FOLLICULAR LYMPHOMA; HEMOLYTIC ANEMIA; HUMAN; INFUSION RELATED REACTION; LEUKOPENIA; LYMPHOCYTOPENIA; NEUTROPENIA; NONHODGKIN LYMPHOMA; PHARMACEUTICS; PHASE 3 CLINICAL TRIAL (TOPIC); PROBABILITY; PURE RED CELL ANEMIA; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; STUDY DESIGN; THROMBOCYTOPENIA; VIRUS INFECTION; ALGORITHM; DRUG APPROVAL; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; STATISTICS; UNITED STATES; WORLD HEALTH ORGANIZATION;

ALGORITHMS; BIOSIMILAR PHARMACEUTICALS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG EVALUATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WORLD HEALTH ORGANIZATION;

MLCS; MLOWN;

EID: 84872371168     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5612     Document Type: Article

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