Practical handbook of clinical investigation

The clinical trials legislation has undergone significant changes in the past years, both in the figures responsible for the authorization process and the procedures to obtain the necessary authorizations. This volume comes from the need to cover an editorial gap and make a reference book available that could be useful for anyone working on clinical trials: for the novice and for those who feel the need to review or investigate themes and concepts already known. The manual deals with the aspects of the clinical trial for the different types of products (medicinal products for human use, medical devices, veterinary drugs, cosmetics, nutraceuticals, ...) without forgetting the fundamental regulatory rules and the necessary theoretical knowledge (methodology and ethics, safety, statistical methods).