Good Practice of Clinical Drug Trials : Translated by R. Coluzzi; J. Young

The success of any new pharmaceutical product depends on the clinical drug trial to give clear scientific proof of efficacy and safety.

Only sufficient quality control guarantees international acceptance of study results.

This book provides an examination of clinical drug trials.

Special features of the text include a chronological presentation of all aspects of trials, including preparation of key study documents, clinical trial drug progression cycle, data processing, adverse events and archiving.

For each function presented, it offers an analytical and synthetic view as well as practical solutions.

It proceeds in a logical sequence and is illustrated with many aide-memoire lists, study diagrams and synoptic tables.

Offering more than just a description of regulations for good clinical practice, it also invites the reader to consider the methodology and finality of drug trials.