Global Biotechnology Product Registration: E.U., U.S. Product Regulation
RGA6220 / 4 q.h.
Formerly RA 3220.
Provides a comprehensive and up-to-date analysis of the biotechnology product approval process within each of the world’s three most critical biopharmaceutical markets. From preclinical product development to postmarketing approval, explores aspects of biopharmaceutical regulatory analyses in the three regions of the world that together represent more than 75 percent of the global market for biopharmaceuticals.
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