Fundamentals of Early Clinical Drug Development (PDF)

An informative look at the intricacies of today's drug development
process

Once a discovery organization has identified a potential new drug
candidate, it is the daunting task of synthetic organic chemists to
identify the chemical process suitable for preparation of this
compound in a highly regulated environment. Only through a
multi-layered chemical process that takes into account such factors
as safety, environmental considerations, freedom to operate and
cost-effectiveness can researchers begin to refine the drug in
terms of quality and yield.

This book covers both recent advances in the design and synthesis
of new drugs, as well as the myriad other issues facing a new drug
candidate as it moves through the development process. Utilizing
recent case studies, the authors provide valuable insights into the
complexities of the process, from designing new synthetic
methodologies and applying new automated techniques for finding
optimal reaction conditions to selecting the final drug form and
formulation.

Both novice and active researchers will appreciate the inclusion of
chapters on such diverse topics as:

* Cross-coupling methods

* Asymmetric synthesis

* Automation

* Chemical Engineering

* Application of radioisotopes

* Final form selection

* Formulations

* Intellectual property

A wealth of real-world examples and contributions from leading
process scientists, engineers, and related professionals make this
book a valuable addition to the scientific literature.