Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics, Biosimilars and Specialty Biologics is a timely and comprehensive look at the process of nonclinical safety assessment of different types of biopharmaceuticals or biologics. Biologic drugs are a growing and crucial part of the overall pharmaceutical market, largely and generally because they are slightly cheaper to produce, provide higher profit margins and have a higher approval rate than conventional drugs. This reference includes the latest international guidance documents on nonclinical evaluation and a comprehensive review of vaccines, novel biopharmaceuticals, biosimilars and other biologics. By incorporating early de-risking strategies and principles of study design for each type of biopharmaceutical and comparing each to small molecule drugs, this multi-authored book is a valuable resource for all those involved in biologics development.

Preface Acknowledgement Dedication