Pharmacokinetics and pharmacodynamics of biotech drugs : principles and case studies in drug development / edited by Bernd Meibohm.
Contributor(s): Meibohm, Bernd [(ed.)].
Publisher: Weinheim : Wiley-VCH, 2006Description: xxi, 403 p. : ill. ; 25 cm.ISBN: 3527314083 (hbk.); 9783527314089 (hbk.).Subject(s): Pharmaceutical biotechnology | Pharmacokinetics | Drugs -- Physiological effect | Drug developmentDDC classification: 615.19Item type | Current location | Shelf location | Call number | Copy number | Status | Notes | Date due | Barcode |
---|---|---|---|---|---|---|---|---|
Main Collection | Taylor's Library-TU |
Floor 4, Shelf 17 , Side 2, TierNo 5, BayNo 7 |
615.19 PHA (Browse shelf) | 1 | Available | SBSxx,36100,03,GR | 5000079843 |
Includes bibliographical references and index.
Foreword. - Preface. - List of contributors. - Pt I: Introduction. - 1. The role of pharmacokinetics and pharmacodynamics in the development of biotech drugs. - Pt. II: The basics. - 2. Pharmacokinetics of peptides and proteins. - 3. Pharmacokinetics of monoclonal antibodies. - 4. Pharmacokinetic and pharmacodynamics of antisense oligonucleotides. - 5. Pharmacokinetics of viral and non-viral gene delivery vectors. - Pt. III: Challenges and opportunities. - 6. Bioanalytical methods used for pharmacokinetic evaluations of biotech macromolecule drugs: issues, assay approaches, and limitations. - 7. Limitations of noncompartmental pharmacokinetic analysis of biotech drugs. - 8. Bioequivalence of biologics. - 9. Biopharmaceutical challenges: pulmonary delivery of proteins and peptides. - 10. Biopharmaceutical challenges: delivery of oligonucleotides. - 11. Custom-tailored pharmacokinetics and pharmacodynamics via chemical modifications of biotech drugs. - 12. Exposure-response relationships for therapeutic biologic products. - Part IV: Examples for the integration of pharmacokinetic and pharmacodynamic concepts into the biotech drug development plan. - 13. Preclinical and clinical drug development of Tasidotin, a depsi-pentapeptide oncolytic agent. - 14. Clinical drug development of Cetuximab, a monoclonal antibody. - 15. Integration of pharmacokinetics and pharmacodynamics into the drug development of Pegfilgrastim, a pegylated protein. - Subject index.