Based on the author's five years of teaching, this book introduces key biotechnology developments and covers critical elements 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. Using simple language and explanatory figures, it describes the functional areasthat must be successfully integrated to bring a biotechnology product to market.
- ISBN: 978-1-4398-3027-7
- Editorial: CRC Press
- Encuadernacion: Cartoné
- Fecha Publicación: 28/03/2011
- Nº Volúmenes: 1
- Idioma: Inglés