Pharmacokinetics and Pharmacodynamics of Biotech Drugs: Principles and Case Studies in Drug Development
John Wiley & Sons, Dec 13, 2006 - Science - 426 pages
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.
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absorption acid activity adalimumab administration aerosol alveolar analyte antigen antisense assay avidin bevacizumab binding bioanalytical bioavailability biological biotech drugs blood cancer cell cetuximab chemotherapy clearance Clin clinical compared concentrations conjugation cytokine diabetes disease dose drug development drug products efalizumab effect elimination etanercept filgrastim formulations G-CSF gene delivery half-life hormone IgG1 immune immunogenicity in-vivo increased inhaled injection insulin interaction interferon intravenous irinotecan ISIS L-chain levels linear liver lung mAbs macromolecules metabolism metabolite method mg/kg mice molecular molecules monoclonal antibodies mRNA neutropenia neutrophil nonlinear oligonucleotide oral parameters pathway patients pegfilgrastim PEGylation peptides peptides and proteins Pharm Pharmaceutical pharmacodynamic Pharmacokinetics and Pharmacodynamics Pharmacol Phase phosphorothioate PK/PD plasma polymer preclinical protein pulmonary delivery rats receptor regimen renal Rituximab route samples serum small-molecule drugs studies target tasidotin Ther therapeutic therapy tinzaparin tion tissue trastuzumab treatment tumor uptake vectors volume of distribution
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