Scientific considerations for assessing biosimilar products

Statistics in Medicine

Volumn 32, Issue 3, 2013, Pages 370-381

  Chow, Shein Chung ^a   Wang, Jun ^a   Endrenyi, Laszlo ^b   Lachenbruch, Peter A ^c  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF TORONTO   (Canada)

^c OREGON STATE UNIVERSITY   (United States)

Author keywords

Alternating; Biosimilarity; Drug interchangeability; Follow on biologics; Switching

Indexed keywords

ALPHA INTERFERON; BEVACIZUMAB; BIOSIMILAR AGENT; HUMAN GROWTH HORMONE; HUMAN INSULIN; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT PROTEIN; TAMOXIFEN;

ARTICLE; BIOEQUIVALENCE; BIOSIMILARITY; CLINICAL TRIAL (TOPIC); DIABETES MELLITUS; DRUG ACTIVITY; DRUG APPROVAL; DRUG IMPURITY; DRUG INTERCHANGEABILITY; DRUG MANUFACTURE; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG STABILITY; DRUG STRUCTURE; FOOD AND DRUG ADMINISTRATION; GROWTH DISORDER; GROWTH HORMONE DEFICIENCY; HUMAN; IMMUNOGENICITY; NONHUMAN; PHARMACEUTICS; PHYSICAL CHEMISTRY; PURE RED CELL ANEMIA; STATISTICAL ANALYSIS; STUDY DESIGN;

ALGORITHMS; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; DRUG EVALUATION; GOVERNMENT REGULATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84872382872     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5571     Document Type: Article

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