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Global Biotechnology Product Registration 1997

- $245.00

This publication, Global Biotechnology Product Registration (1997), provides a comprehensive analysis of the Center for Biologics Evaluation and Research (CBER) and its review process for biological and biotechnology products. Global Biotechnology Product Registration is divided into three discrete sections covering the European Union, the United States, and Japan. From preclinical product development to postmarketing approval, each section provides comprehensive and up-to-date analyses of the biotechnology product approval process in a different major market.

By Mark M. Struck, Ph.D., Mark Mathieu, and Hiromi Okabe, Ph.D.

ISBN #1-882615-32-8 Softcover.