Pharmacokinetics and Pharmacodynamics of Biotech Drugs Principles and Case Studies in Drug Development

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.

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

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'.