This work covers all the safety aspects of clinical drug development and post-marketing surveillance, as well as the general background to adverse drug reactions and their collection. The chapter on laboratory investigations has been trebled in size and includes new approaches from around the world. There is extensive advice on the collection, storage, retrieval and management of adverse reaction data. The regulations from France, Germany, Japan, Italy, Scandinavia, USA, UK and the EC have been brought up to date. A new chapter on causality assessment has also been written.