Evaluation of similar biotherapeutic products: Scientific and regulatory challenges

Biologicals

Volumn 39, Issue 5, 2011, Pages 249-

  Griffiths, Elwyn ^a   Thorpe, Robin ^b   Wadhwa, Meenu ^b   Sohn, Yeowon ^c  

^a HEALTH CANADA   (Canada)

^b NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^c Korea Food and Drug Administration   (South Korea)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; SIMILAR BIOTHERAPEUTIC PRODUCT; UNCLASSIFIED DRUG;

DRUG INDUSTRY; DRUG SCREENING; EDITORIAL; PEER REVIEW; PRIORITY JOURNAL; SCIENTIFIC LITERATURE; STANDARDIZATION; WORLD HEALTH ORGANIZATION;

CONGRESSES AS TOPIC; DRUG INDUSTRY; GUIDELINES AS TOPIC; LEGISLATION, DRUG; PHARMACEUTICAL PREPARATIONS; WORLD HEALTH ORGANIZATION;

EID: 80053567619     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.09.004     Document Type: Editorial

References (0)