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.Content:
Chapter 1 The Role of Pharmacokinetics and Pharmacodynamics in the Development of Biotech Drugs (pages 1–13): Prof. Dr. Bernd Meibohm
Chapter 2 Pharmacokinetics of Peptides and Proteins (pages 15–43): Lisa Tang and Prof. Dr. Bernd Meibohm
Chapter 3 Pharmacokinetics of Monoclonal Antibodies (pages 45–91): Katharina Kuester and Charlotte Kloft
Chapter 4 Pharmacokinetics and Pharmacodynamics of Antisense Oligonucleotides (pages 93–120): Rosie Z. Yu, Richard S. Geary and Arthur A. Levin
Chapter 5 Pharmacokinetics of Viral and Non?Viral Gene Delivery Vectors (pages 121–144): Martin Meyer, Gururaj Rao, Ke Ren and Jeffrey Hughes
Chapter 6 Bioanalytical Methods Used for Pharmacokinetic Evaluations of Biotech Macromolecule Drugs: Issues, Assay Approaches, and Limitations (pages 145–180): Jean W. Lee
Chapter 7 Limitations of Noncompartmental Pharmacokinetic Analysis of Biotech Drugs (pages 181–188): Arthur B. Straughn
Chapter 8 Bioequivalence of Biologics (pages 189–208): Jeffrey S. Barrett
Chapter 9 Biopharmaceutical Challenges: Pulmonary Delivery of Proteins and Peptides (pages 209–242): Kun Cheng and Ram I. Mahato
Chapter 10 Biopharmaceutical Challenges: Delivery of Oligonucleotides (pages 243–269): Lloyd G. Tillman and Gregory E. Hardee
Chapter 11 Custom?Tailored Pharmacokinetics and Pharmacodynamics via Chemical Modifications of Biotech Drugs (pages 271–294): Francesco M. Veronese and Paolo Caliceti
Chapter 12 Exposure–Response Relationships for Therapeutic Biologic Products (pages 295–327): Mohammad Tabrizi and Lorin K. Roskos
Chapter 13 Preclinical and Clinical Drug Development of Tasidotin, a Depsi?Pentapeptide Oncolytic Agent (pages 329–351): Peter L. Bonate, Larry Arthaud and Katherine Stephenson
Chapter 14 Clinical Drug Development of Cetuximab, a Monoclonal Antibody (pages 353–371): Arno Nolting, Floyd E. Fox and Andreas Kovar
Chapter 15 Integration of Pharmacokinetics and Pharmacodynamics into the Drug Development of Pegfilgrastim, a Pegylated Protein (pages 373–393): Bing?Bing Yang