Publisher's Synopsis
Based on the author's five years of teaching this book introduces key biotechnology developments covering the critical elements of such as project management, regulatory affairs, quality assurance, biomanufacturing, quality control, nonclinical safety testing, and clinical evaluation. The author discusses these subjects in relation to development planning, process and pathways, management of integrated projects and the business and economic aspects of development. It describes the functional areas that must be successfully integrated to bring a biotechnology product to market, using simple language and explanatory figures.
