ABSTRACT

This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points.

chapter 2|36 pages

Project Management

chapter 3|47 pages

Regulatory Affairs

chapter 4|36 pages

Regulatory Compliance

chapter 5|46 pages

Quality Systems

chapter 6|68 pages

Biomanufacture

chapter 7|57 pages

Quality Control

chapter 8|50 pages

Nonclinical Studies

chapter 9|47 pages

Clinical Trials