ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins
Autor: | Honghui Zhou, Frank-Peter Theil |
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EAN: | 9781118898741 |
eBook Format: | ePUB |
Sprache: | Englisch |
Produktart: | eBook |
Veröffentlichungsdatum: | 26.10.2015 |
Untertitel: | Applications in Drug Discovery and Development |
Kategorie: | |
Schlagworte: | <p>Therapeutic proteins ADME biologic drugs clinical pharmacology monoclonal antibodies pharmacokinetics and pharmacodynamics protein engineering target-driven pharmacokinetics therapeutic antibodies translational PK/PD tumor effect c |
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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
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).