Erratum: Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars? [AAPS J, DOI 10.1208/s12248-013-9534-y];Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars?

AAPS Journal

Volumn 16, Issue 1, 2014, Pages 22-26

  Lee, Howard ^a  

^a Seoul National University Hospital   (South Korea)

Author keywords

Biosimilars; CT P13; Extrapolation of indication; Infliximab; Regulatory agency

Indexed keywords

ANTIRHEUMATIC AGENT; BIOSIMILAR AGENT; CTP 13; ETANERCEPT; INFLIXIMAB; METHOTREXATE; PLACEBO; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG;

ANKYLOSING SPONDYLITIS; ANTIINFLAMMATORY ACTIVITY; ARTICLE; COMBINATION CHEMOTHERAPY; CROHN DISEASE; DOSE RESPONSE; DRUG CONTROL; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG EXPOSURE; DRUG INDICATION; DRUG PROGRAM; DRUG RESEARCH; DRUG SAFETY; DRUG SENSITIVITY; HUMAN; IMMUNOGENICITY; INFLAMMATORY BOWEL DISEASE; PSORIASIS VULGARIS; PSORIATIC ARTHRITIS; RECOMMENDED DRUG DOSE; RHEUMATOID ARTHRITIS; TREATMENT OUTCOME; ULCERATIVE COLITIS;

ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOSIMILAR PHARMACEUTICALS; DRUG AND NARCOTIC CONTROL; HUMANS; IMMUNOGENETIC PHENOMENA; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84893044719     PISSN: 15507416     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-015-9813-x     Document Type: Erratum

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