Drug Safety Evaluation: Methods and Protocols

Drug discovery and development is a long and expensive process. It is estimated to take an average of 10–15 years and up to $800 million to develop a new drug. Furthermore, on average only five out of 250 compounds selected from in vitro drug discovery programs for pre-clinical testing will enter clinical trials. In the majority of cases this is because either the compound did not show sufficient therapeutic activity in vivo or it had adverse effects and was therefore considered unsafe. Non-clinical safety assessment is an important component of the overall drug development plans for new drug candidates (leads) and biologics. Laboratory studies including in vitro and in animals systems, are an essential step in the progress of new pharmaceuticals heading toward the ultimate goal of clinical trials and, eventually, approval. In the book Drug Safety Evaluation: Methods and Protocols, expert researchers detail a compendium of analytical technologies with a focus on applicability in real life laboratory practice. As a volume in the successful Methods in Molecular Biology ™ series, chapters include brief introductions to their respective subjects, lists of the necessary materials, step-by-step guides through the techniques and protocols. The book is divided into eight parts. Part I