Pharmacokinetics and Pharmacodynamics of Biotech Drugs

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The characterization and optimization of pharmacokinetic properties and exposure-response relationships are crucial parts in the drug development of biotechnologically-derived drug products. Until recently, our understanding of pharmacokinetics and pharmacodynamics was limited to 'traditional' small-molecule, non-biological drugs. Now, with the current boom in drugs based on biological molecules, such as proteins and nucleotides, there is an urgent need to understand the pharmacokinetic and pharmacodynamic characteristics of these very different types of drugs. This book meets that need. Comprehensive in its coverage, it spans relevant topics from early phase drug development right up to late-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the first section covers 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 challenges and opportunities in the pharmaceutical development of biologics, including issues related to bioanalytical assays, bioequivalence and exposure-response assessments, as well as drug delivery. 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 set by cetuximab and pegfilgrastim. Vital reading for all pharmaceutical scientists working with biologics.