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Volumn 32, Issue 2, 2014, Pages 128-130

Biologic product identification and US pharmacovigilance in the biosimilars era

Author keywords

[No Author keywords available]

Indexed keywords

ADVERSE DRUG REACTION REPORTING SYSTEMS; BIOSIMILAR PHARMACEUTICALS; HUMANS; PATIENT SAFETY; PHARMACOVIGILANCE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84893870832     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt.2823     Document Type: Letter
Times cited : (15)

References (11)
  • 7
    • 84893841672 scopus 로고    scopus 로고
    • Booz Allen Hamilton. US Food and Drug Administration Contract No. HHSF223200831321P (Booz Allen Hamilton, Rockville, MD, 2010 (accessed 17 January
    • Booz Allen Hamilton. Evaluation of Potential Data Sources for the FDA Sentinel Initiative-Final Report. US Food and Drug Administration Contract No. HHSF223200831321P (Booz Allen Hamilton, Rockville, MD, 2010). http://www.regulations.gov/cont entStreamer?objectId= 0900006480e6cd8d&dispositio n=attachment&contentType=pdf (accessed 17 January 2014
    • (2014) Evaluation of Potential Data Sources for the FDA Sentinel Initiative-Final Report
  • 8
    • 84893873158 scopus 로고    scopus 로고
    • Drug Administration. FDA, Silver Spring, MD, November 2 2010 FDA, Silver Spring MD, 2 November 2010; accessed 17 January US Food and
    • US Food and Drug Administration. Part 15 Public Hearing on Approval Pathway for Biosimilar and Interchangeable Biological Products. (FDA, Silver Spring, MD, November 2, 2010). http://www.fda. gov/downloads/Drugs/NewsEvents/ UCM289130.pdf (FDA, Silver Spring, MD, 2 November 2010; accessed 17 January 2014
    • (2014) Part 15 Public Hearing on Approval Pathway for Biosimilar and Interchangeable Biological Products
  • 10
    • 84893850025 scopus 로고    scopus 로고
    • US Food and Drug Administration FDA, Center for Drug Evaluation and Research, Rockville MD
    • US Food and Drug Administration. Proprietary Name Review(s): BLA 125294 -[xxx]-Filgrastim (FDA, Center for Drug Evaluation and Research, Rockville, MD, 2012
    • (2012) Proprietary Name Review(s): BLA 125294 -[xxx]-Filgrastim


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.