Ligand-binding assays
Subtitle: development, validation, and implementation in the drug development arena
By: [edited by] Masood N. Khan, John W.A. Findlay.
Contributors: Khan, Masood N.; Findlay, John W. A.
Publisher: Wiley
Published: 2009
Place of publication: Hoboken, N.J
Language: eng
ISBN-13: 9780470041383
Subjects: Radioligand assay; Drug development; Drug Design; Immunoassay; Ligands; Protein Binding
Table of contents: title: Introduction and historical perspective / John W.A. Findlay and Masood N. Khan; title: Ligand-binding assays to support disposition studies of macromolecular therapeutics / Marian M. Kelley, Marjorie A. Mohler, and John W.A. Findlay; title: Development of ligand-binding assays for drug development support / Masood Khan ... [et al.]; title: Validation of ligand-binding assays to support pharmacokinetic assessments of biotherapeutics / Binodh Desilva and Ronald R. Bowsher; title: Statistical considerations in the validation of ligand-binding assays / Bruno Boulanger, Viswanath Devanarayan, and Walthere Dewe; title: Development and validation of ligand-binding assays for biomarkers / Jean W. Lee ... [et al.]; title: The use of commercial assay kits for PK/PD analysis in drug development / John L. Allinson and John D. Chappel; title: Development and validation of immunogenicity assays for pre-clinical and clinical studies / Thomas Parish, Deborah Finco-Kent, and Viswanath Devanarayan; title: Macromolecular reference standards for biotherapeutic pharmacokinetic analysis / Marie T. Rock and Stephen Keller; title: Strategies for transfer of ligand-binding assays for successful validation and implementation in GXP environments / Wolfgang Klump and Howard Hill; title: Application of automation in ligand-binding assays / Chris Morrow; title: Documentation and regulatory compliance / Jacqueline A. O'Shaughnessy and C.T. Viswanathan; title: Alternative and emerging methodologies in ligand-binding assays / Huifen F. Wang and John W.A. Findlay.