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OverviewThis first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary delivery of proteins and peptides, and the delivery of oligonucleotides. The final section considers the integration of PK and PD concepts into the biotech drug development plan, taking as case studies the preclinical and clinical drug development of tasidotin, as well as the examples of cetuximab and pegfilgrastim. The result is vital reading for all pharmaceutical researchers. Full Product DetailsAuthor: Bernd Meibohm (University of Tennessee Health Science Center, Memphis, TN, USA)Publisher: Wiley-VCH Verlag GmbH Imprint: Blackwell Verlag GmbH Dimensions: Width: 17.80cm , Height: 2.60cm , Length: 24.60cm Weight: 0.925kg ISBN: 9783527314089ISBN 10: 3527314083 Pages: 426 Publication Date: 10 October 2006 Audience: Professional and scholarly , Professional & Vocational Format: Hardback Publisher's Status: Active Availability: Out of stock The supplier is temporarily out of stock of this item. It will be ordered for you on backorder and shipped when it becomes available. Table of ContentsThe Role of Pharmacokinetics and Pharmacodynamics in the Development of Biotech Drugs Pharmacokinetics of Peptides and Proteins Pharmacokinetics of Monoclonal Antibodies Pharmacokinetics and Pharmacodynamics of Antisense Oligonucleotides Pharmacokinetics of Viral and Non-Viral Gene Delivery Vectors Bioanalytical Methods used for Pharmacokinetic Evaluations of Biotech Macromolecule Drugs: Issues, Assay Approaches, and Limitations Limitations of Noncompartmental Pharmacokinetic Analysis of Biotech Drugs Bioequivalence of Biologics Biopharmaceutical Challenges in Pulmonary Delivery of Proteins and Peptides Biopharmaceutical Challenges: Delivery of Oligonucleotides Custom-Tailored Pharmacokinetics and Pharmacodynamics via Chemical Modifications of Biotech Drugs Exposure-Response Relationships for Therapeutic Biologic Products Preclinical and Clinical Drug Development of Tasidotin, a Depsi-Pentapeptide Oncolytic Agent Clinical Drug Development of Cetuximab, a Monoclonal Antibody Integration of Pharmacokinetics and Pharmacodynamics into the Drug Development of Pegfilgrastim, a Pegylated ProteinReviews... There is an urgent need to understand the PK and PD characteristics of these different types of drugs. This book meets that need. ... Anticancer Research ""... There is an urgent need to understand the PK and PD characteristics of these different types of drugs. This book meets that need. ..."" Anticancer Research ... There is an urgent need to understand the PK and PD characteristics of these different types of drugs. This book meets that need. ... Anticancer Research Author InformationBernd Meibohm is an Associate Professor of Pharmaceutical Sciences at the College of Pharmacy of the University of Tennessee Health Science Center, Memphis. He obtained his PhD from the University Carolo-Wilhelmina in Braunschweig, Germany, and underwent postdoctoral training in clinical pharmacology at the University of Florida, Gainesville. His research is focused on pharmacokinetics (PK), pharmacodynamics (PD), and pharmacogenetics (PG) with special emphasis on PK/PD/PG correlations. Professor Meibohm is a Fellow of the American College of Clinical Pharmacology (ACCP) and has received numerous awards, including the 'Young Investigator Award in PK, PD and Drug Metabolism' from the American Association of Pharmaceutical Scientists (AAPS) in 2000. He is currently serving as Section Editor for PK and PD for the 'Journal of Clinical Pharmacology' and on the Editorial Boards of the 'Journal of Pediatric Pharmacology and Therapeutics' and 'Die Pharmazie'. Tab Content 6Author Website:Countries AvailableAll regions |
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