With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs.

* Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs
* Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective
* Includes case studies about leveraging ADME to improve biologics drug development for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines
* Presents regulatory expectations and industry perspectives for developing biologic drugs in USA, EU, and Japan
* Provides mechanistic insight into biodistribution and target-driven pharmacokinetics in important sites of action such as tumors and the brain

About the Author
Honghui Zhou is a Senior Director and Janssen Fellow, at Janssen Research & Development, LLC and US head of Pharmacological and Translational Modeling. Board-certified by the American Board of Clinical Pharmacology and a Fellow of American Association of Pharmaceutical Scientists (AAPS) and American College of Clinical Pharmacology (ACCP), he has authored 200 peer-reviewed scientific papers, book chapters, and conference abstracts and co-edited the book Drug-Drug Interactions for Therapeutic Biologics (Wiley, 2013).

Frank-Peter Theil heads nonclinical development at UCB Biopharma. Dr. Theil has authored and co-authored 40 research publications, three book chapters and he has given numerous invited presentations at national and international scientific meetings. He is a member of the American Association of Pharmaceutical Scientists (AAPS) and American Society of Clinical Pharmacology and Therapeutics (ASCPT).

Reviews

"At the outset, one s impressed with the scope of the book; it provides an outline of very diverse topics starting with the basics of protein engineering and how these are used to design and manipulate the ADME properties of recombinant and synthetic proteins...The authors have to be congratulated on their endeavor to stitch these topics together in a single book...With such a wide range of topics, even an experienced scientific practitioner in this area is likely to find something new to engage them and expand their knowledge...In summary, an excellent and comprehensive book for beginners to the CP/PK area to acquaint themselves with the area of biologics (specifically mAb) CP/PKPD principles and for experienced CP/PK scientists for reference." (CPT: Pharmacometrics & Systems Pharmacology, March 2017)

Book Information
ISBN 9781118898642
Author Honghui Zhou
Format Hardback
Page Count 480
Imprint John Wiley & Sons Inc
Publisher John Wiley & Sons Inc
Weight(grams) 1352g
Dimensions(mm) 287mm * 224mm * 31mm