Assessing switchability for biosimilar products: Modelling approaches applied to children's growth

Pharmaceutical Statistics

Volumn 14, Issue 4, 2015, Pages 341-349

  Belleli, Rossella ^a   Fisch, Roland ^a   Renard, Didier ^b   Woehling, Heike ^a   Gsteiger, Sandro ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

^b Sandoz Biopharmaceuticals   (Germany)

Author keywords

biosimilar; interchangeability; statistical modelling; Switchability

Indexed keywords

BIOSIMILAR AGENT; HUMAN GROWTH HORMONE;

ARTICLE; BODY HEIGHT; CHILD GROWTH; DRUG SUBSTITUTION; DRUG WITHDRAWAL; GROWTH HORMONE DEFICIENCY; GROWTH RATE; MEASUREMENT ACCURACY; MEASUREMENT PRECISION; MULTICENTER STUDY (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PREDICTION; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICAL MODEL; ADOLESCENT; AGE; CHILD; CHILD DEVELOPMENT; DRUG EFFECTS; HUMAN; MEDICINAL CHEMISTRY; METHODOLOGY; PROCEDURES; STATISTICAL ANALYSIS; STATISTICS AND NUMERICAL DATA; TIME FACTOR; TREATMENT OUTCOME;

ADOLESCENT; AGE FACTORS; BIOSIMILAR PHARMACEUTICALS; BODY HEIGHT; CHEMISTRY, PHARMACEUTICAL; CHILD; CHILD DEVELOPMENT; CLINICAL TRIALS, PHASE III AS TOPIC; DATA INTERPRETATION, STATISTICAL; DRUG SUBSTITUTION; HUMAN GROWTH HORMONE; HUMANS; MODELS, STATISTICAL; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME;

EID: 84937022739     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.1691     Document Type: Article

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