Pharmacokinetics and Pharmacodynamics of Biotech Drugs

Principles and Case Studies in Drug Development
1. Auflage 2006
ISBN: 978-3-527-31408-9
Verlag: WILEY-VCH

Buch, Englisch, 404 Seiten, Format (B × H): 178 mm x 246 mm, Gewicht: 925 g

This 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.

Zielgruppe

Biotechnologen, Pharmazeuten, Toxikologen, Medizinische Chemiker

Autoren/Hrsg.

Meibohm, Bernd

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Kosmetische Technologie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie Industrielle Biotechnologie

Inhaltsverzeichnis

The 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 Protein

Über Autor(innen)

Bernd 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'.