Considerations for biosimilar monoclonal antibody development: Lessons learned from clinical trials of trastuzumab

Chinese Journal of Cancer Biotherapy

Volumn 21, Issue 4, 2014, Pages 359-365

  Guo, Wei ^a   Chen, Yuqin ^a   Wang, Junzhi ^a  

^a NATIONAL INSTITUTES FOR FOOD AND DRUG CONTROL   (China)

Author keywords

Biosimilar; Clinical trial design; Monoclonal antibody; Trastuzumab

Indexed keywords

BIOSIMILAR AGENT; MONOCLONAL ANTIBODY; TRASTUZUMAB;

ARTICLE; BREAST CANCER; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG LABELING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPEAN MEDICINES AGENCY; HUMAN; PATIENT SAFETY; PRACTICE GUIDELINE; STUDY DESIGN;

EID: 84907657319     PISSN: 1007385X     EISSN: None     Source Type: Journal    
DOI: 10.3872/j.issn.1007-385X.2014.04.001     Document Type: Article

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