ABSTRACT
INTRODUCTION The development of new pharmaceutical or biotechnology-derived products undergoes a lengthy and expensive cycle, which is adequately described elsewhere in the book. Given the cost of development now hovering around the billion dollar mark for each new drug, amortized over all other molecules under development, the only way to protect this investment is to create intellectual property claims to not only the active molecule but where possible, each and every step of its production, processing, and testing. Almost 4% of the development cost is spent on filing and prosecuting patents. Preformulation scientists play an important role in creating intellectual property because at this stage the specifications of the new drug entity are defined, and often newer lead compounds are substituted.
