ABSTRACT
Although the purpose of this book is not to serve as a guideline for all aspects of biopharmaceutical development, and even less as a guideline to regulatory compliance, acquiring a general idea of these subjects is of increasing importance to the understanding of the development of biological drugs and ultimately to the role of analysts in the process. The following introduction is meant as a bird’seye view of the landscape for scientists who are new to the field or are removed from big-picture considerations of their particular projects.
