MARC状态：订购 文献类型：西文图书 浏览次数：5
- 题名/责任者:
- Ligand-binding assays : development, validation, and implementation in the drug development arena / edited by Masood N. Khan, John W.A. Findlay.
- 出版发行项:
- Hoboken, N.J. : Wiley, c2010.
- ISBN:
- 0470041382 (cloth)
- ISBN:
- 9780470041383 (cloth)
- 载体形态项:
- xvi, 403 p. : ill. ; 25 cm.
- 附加个人名称:
- Findlay, John W. A.
- 附加个人名称:
- Khan, Masood N.
- 论题主题:
- Protein Binding.
- 论题主题:
- Ligands.
- 论题主题:
- Immunoassay.
- 论题主题:
- Drug Design.
- 论题主题:
- Drug development.
- 论题主题:
- Radioligand assay.
- 中图法分类号:
- R914
- 书目附注:
- Includes bibliographical references and index.
- 内容附注:
- The use of commercial assay kits for PK/PD analysis in drug development / John L. Allinson and John D. Chappell -- Development and validation of immunogenicity assays for preclinical and clinical studies / Thomas H. Parish, Deborah Finco, and Viswanath Devanarayan -- Macromolecular reference standards for biotherapeutic pharmacokinetic analysis / Marie T. Rock and Stephen Keller -- Strategies for successful transfer of ligand-binding assays for successful validation and implementation in GXP environment / Wolfgang Klump and Howard Hill -- Application of automation in ligand-binding assays / Chris Morrow -- Documentation and regulatory compliance / C.T. Viswanathan and Jacqueline A. O'Shaughnessy -- Alternative and emerging methodologies in ligand-binding assays / Huifen F. Wang and John W.A. Findlay.
- 内容附注:
- Introduction and historical perspective / John W.A. Findlay and Masood N. Khan -- Ligand-binding assays to support disposition studies of macromolecular therapeutics / Marian M. Kelley, Marjorie A. Mohler, and John W.A. Findlay -- Development of ligand-binding assays for drug development support / Masood Khan ... [et al.] -- Validation of ligand-binding assays to support pharmacokinetic assessments of biotherapeutics / Binodh Desilva and Ronald R. Bowsher -- Statistical considerations in the validation of ligand-binding assays / Bruno Boulanger, Viswanath Devanarayan, and Walthere Dewe -- Development and validation of ligand-binding assays for biomarkers / Jean W. Lee ... [et al.].
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