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KMID : 1142220110060010085
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Regulatory Research on Food, Drug & Cosmetic
2011 Volume.6 No. 1 p.85 ~ p.97
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Investigation for Demand of Biopharmaceutical Companies for Research and Development Projects in Korea
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Park Ki-Dae
Kim Seon-Hee
Kang So-Young
Choi Min-Joung
Yoo Si-Hyung
Baek Sun-Young
Kim Dong-Sub
Kang Shin-Jung
Oh Il-Ung
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Abstract
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Korea Food and Drug Administration (KFDA) conducted a study to investigate the need of pharmaceutical companies for R&D projects. In this study, we found that the biopharmaceutical companies are highly interested and invested in the monocolonal antibodies. Moreover, it was observed that advanced biopharmaceuticals including monoclonal antibodies, cell therapy were the ones which KFDA support is needed the most. There were also huge demands among those companies for KFDA's assistance in areas of review and approval. In addition, it was observed that companies which produced vaccines needed practical assistance regarding production of samples for clinical trials. Results of this study were similar to the international analytical reports on biopharmaceuticals.
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KEYWORD
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Biopharmaceuticals, Investigation, Research, Monoclonal antibody, KFDA
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