Ligand-binding assays : development, validation, and implementation in the drug development arena /
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| Other Authors: | , |
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| Format: | Book |
| Language: | English |
| Published: |
Hoboken, N.J. :
Wiley,
2010
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| Subjects: |
Table of Contents:
- 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.].
- 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.
