A Fresh Look at Drug Approval: Moving Away From Tradition

Overview

Approval of novel drugs is complicated. Drug discovery and further implementation of it to market is a key to innovative medicine and improved medical care. Some difficulties hold up the licensure process and spread of drugs. 

Hematology is extremely important sphere of medicine. That is why its development and implementation of new drugs here has high profile. We know that some diseases are infrequent, with different biologies but morphologically similar. To understand the biology of specific conditions scientists need to investigate the molecular level. 

All these peculiarities result in new but specific forms of treatment and medicines. Sometimes it leads to cure and in some cases to remission. Authors of the book concentrate on stages of drug development. The aim is to provide a reader with a detailed overview of the development process, their validation and monitoring after approval. 

The authors of the book are Dr. Victoria Richon, Dr. Michael Grever and Dr. Mark Crowther. 

Victoria Richon provides an overview of the first step in drugs development. She starts with scientific observation from the basic science lab and moves to clinical trial. She makes an emphasis on rare diseases.  

Dr. Miichael Grever explores licensure and makes an overview of optimal ways of drugs approval.

Dr. Mark Crowther uses real examples and emphasizes on the importance of the period after medicine approval for its further use in clinics and its regulation.