| Description |
1 online resource (xxi, 403 pages) : illustrations |
| Contents |
The role of pharmacokinetics and pharmacodynamics in the development of biotech drugs / Bernd Meibohm -- Pharmacokinetics of peptides and proteins / Lisa Tang, Bernd Meibohm -- Pharmacokinetics of monoclonal antibodies / Katharina Kuester, Charlotte Kloft -- Pharmacokinetics and pharmacodynamics of antisense oligonucleotides / Rosie Z. Yu, Richard S. Geary, Arthur A. Levin -- Pharmacokinetics of viral and non-viral gene delivery vectors / Martin Meyer, Gururaj Rao, Ke Ren, Jeffrey Hughes -- Bioanalytical methods used for pharmacokinetic evaluations of biotech macromolecule drugs : issues, assay approaches, and limitations / Jean W. Lee -- Limitations of noncompartmental pharmacokinetic analysis of biotech drugs / Arthur B. Straughn -- Bioequivalence of biologics / Jeffrey S. Barrett -- Biopharmaceutical challenges: pulmonary delivery of proteins and peptides / Kun Cheng, Ram I. Mahato -- Biopharmaceutical challenges : delivery of oligonucleotides / Lloyd G. Tillman, Gregory E. Hardee -- Custom-tailored pharmacokinetics and pharmacodynamics via chemical modifications of biotech drugs / Francesco M. Veronese, Paolo Caliceti -- Exposure-response relationships for therapeutic biologic products / Mohammad Tabrizi, Lorin K. Roskos -- Preclinical and clinical drug development of tasidotin, a depsi-pentapeptide oncolytic agent / Peter L. Bonate, Larry Arthaud, Katherine Stephenson -- Clinical drug development of cetuximab, a monoclonal antibody / Arno Nolting, Floyd E. Fox, Andreas Kovar -- Integration of pharmacokinetics and pharmacodynamics into the drug development of pegfilgrastim, a pegylated protein / Bing-Bing Yang |
| Summary |
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 de |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Drug development.
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Drugs -- Physiological effect.
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Pharmaceutical biotechnology.
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Pharmacokinetics.
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Biotechnology -- methods.
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Drug Design.
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Pharmaceutical Preparations -- metabolism.
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Pharmacokinetics.
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Pharmacology -- methods.
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| Form |
Electronic book
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| Author |
Meibohm, Bernd, editor
|
| ISBN |
3527609520 (electronic bk.) |
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3527609628 |
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9783527609529 (electronic bk.) |
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9783527609628 |
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(alk. paper) |
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(alk. paper) |
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