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.
Table of contents
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
"... There is an urgent need to understand the PK and PD characteristics of these different types of drugs. This book meets that need. ..."