机读格式显示(MARC)

• 000 02595cam a2200361 a 4500

• 001 0000852464

• 003 CAL

• 005 20101015155052.1

• 008 090901s2010 njua b 001 0 eng

• 010 __ |a 2009036489

• 020 __ |a 0470041382 (cloth)

• 020 __ |a 9780470041383 (cloth)

• 035 __ |a (OCoLC)ocn326670293

• 040 __ |a DNLM/DLC |c DLC |d NLM |d BTCTA |d C#P |d YDXCP |d SDB |d DLC

• 042 __ |a pcc

• 050 00 |a RS425 |b .L54 2010

• 082 00 |a 615/.19 |2 22

• 093 __ |a R914 |2 4

• 099 __ |a CAL 022010204849

• 245 00 |a Ligand-binding assays : |b development, validation, and implementation in the drug development arena / |c edited by Masood N. Khan, John W.A. Findlay.

• 260 __ |a Hoboken, N.J. : |b Wiley, |c c2010.

• 300 __ |a xvi, 403 p. : |b ill. ; |c 25 cm.

• 504 __ |a Includes bibliographical references and index.

• 505 0_ |a 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.

• 505 0_ |a 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.].

• 650 22 |a Protein Binding.

• 650 22 |a Ligands.

• 650 22 |a Immunoassay.

• 650 12 |a Drug Design.

• 650 _0 |a Drug development.

• 650 _0 |a Radioligand assay.

• 700 1_ |a Findlay, John W. A.

• 700 1_ |a Khan, Masood N.