1 |
Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for industry: Scientific considerations in demonstrating biosimilarity to a reference product (Draft). 2012./
|
|
2 |
World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs). 2012./
|
|
3 |
McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther, 2012;91(3):405-417./
|
|
4 |
American Society for Clinical Pharmacology and Therapeutics. Web sites on the Scientific Sections for the American Society for Clinical Pharmacology and Therapeutics. http://www. ascpt.org/MyASCPT/ScientificSections/tabid/66 52/Default.aspx [Online] (last visited on 13 May 2012)./
|
|
5 |
American Society for Clinical Pharmacology & Therapeutics. Clin Pharmacol Ther, 2012;91(5):753-768./
|
|
6 |
KFDA Press release. http://www.kfda.go.kr/ index.kfda?mid=56&seq=16432&cmd=v. [Online] (last visited on 21 November 2012)/
|
|
7 |
Korea National Enterprise For Clinical Trials (KoNECT). [통계] 한국의 임상시험 현황. http://www.konect.or.kr/bbs/board/boardView.action?bbsId= 19&thisPage= 1&searchField=&sear chWord=&bcId=1127 [Online] (last visited on 21 November 2012)/
|
|
8 |
KoNECT. Available from; http://wwwkonect. or.kr/bbs/boardView.action?bbsId= 1&bcld= 1254&thisPage=6&searchField=bcTitle&searchWord= [Online] (last visited on 21 November 2012)/
|
|
9 |
KoNECT Press release. Available from; http://www.konect.or.kr/bbs/board/boardView.action?bbsId=2&header=07&sub=02&bcId= 1335&thisPage= l&searchField=&search Word= [Online] (last visited on 21 November 2012)/
|
|
10 |
KFDA. Korea good clinical practice (KGCP) guidelines. http://clinicaltrials.kfda.go.kr/guide/ laws/board_list.jsp?category_seq=12 [Online] (last visited on 07 July 2012)./
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