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010   $a9786610722914
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100   $a20060112d2006      uy             0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aPharmacokinetics and pharmacodynamics of biotech drugs $eprinciples and case studies in drug development /$fedited by Bernd Meibohm
210   $aWeinheim, Germany $cWiley-VCH$dc2006
215   $a1 online resource (427 pages)
300   $aDescription based upon print version of record.
311   $a3-527-31408-3 
320   $aIncludes bibliographical references and index.
327   $a1. The Role of Pharmacokinetics and Pharmacodynamics in the Development of Biotech Drugs -- 2. Pharmacokinetics of Peptides and Proteins -- 3. Pharmacokinetics of Monoclonal Antibodies -- 4. Pharmacokinetics and Pharmacodynamics of Antisense Oligonucleotides -- 5. Pharmacokinetics of Viral and Non-Viral Gene Delivery Vectors -- 6. Bioanalytical Methods Used for Pharmacokinetic Evaluationsof Biotech Macromolecule Drugs: Issues, Assay Approaches, and Limitations -- 7. Limitations of Noncompartmental Pharmacokinetic Analysisof Biotech Drugs -- 8. Bioequivalence of Biologics -- 9. Biopharmaceutical Challenges: Pulmonary Delivery of Proteinsand Peptides -- 10. Biopharmaceutical Challenges: Delivery of Oligonucleotides -- 11. Custom-Tailored Pharmacokinetics and Pharmacodynamicsvia Chemical Modifications of Biotech Drugs -- 12. Exposure?Response Relationships for Therapeutic BiologicProducts -- 13. Preclinical and Clinical Drug Development of Tasidotin,a Depsi-Pentapeptide Oncolytic Agent.
330   $aThis 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.--publisher.
606   $aPharmaceutical biotechnology
606   $aPharmacokinetics
606   $aDrugs$xPhysiological effect
606   $aDrug development
608   $aElectronic books.
615  0$aPharmaceutical biotechnology.
615  0$aPharmacokinetics.
615  0$aDrugs$xPhysiological effect.
615  0$aDrug development.
676   $a615.19
702   $aMeibohm$b Bernd
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910144562503321
996   $aPharmacokinetics and pharmacodynamics of biotech drugs$92054471
997   $aUNINA