Ligand-Binding Assays: Development, Validation, and by Masood N. Khan, John W. Findlay PDF

By Masood N. Khan, John W. Findlay

A consolidated and entire reference on ligand-binding assaysLigand-binding assays (LBAs) stand because the cornerstone of help for definition of the pharmaco-kinetics and toxicokinetics of macromolecules, a space of burgeoning curiosity within the pharmaceutical undefined. but, open air of the Crystal urban convention complaints, little suggestions has been to be had for LBA validation, quite for assays used to help macromolecule drug improvement. Ligand-Binding Assays: improvement, Validation, and Implementation within the Drug improvement area solutions that starting to be want, serving as a reference textual content discussing severe points of the advance, validation, and implementation of ligand-binding assays within the drug improvement field.Ligand-Binding Assays covers crucial themes relating to ligand-binding assays, from pharmacokinetic reports, the improvement of LBAs, assay validation, statistical LBA elements, and regulatory features, to software program for LBAs and robotics and different rising methodologies for LBAs. Highlights include:A basic dialogue of demanding situations and confirmed techniques within the improvement of ligand-binding assaysMore exact exam of features of those assays while utilized to help of pharmacokinetic and toxicokinetic reports of compounds at diversified levels within the discovery or improvement timelineA concise, yet specific, dialogue of validation of ligand-binding assays for macromoleculesA sensible method of "fit-for-purpose" validation of assays for biomarkers, these molecules receiving elevated awareness as most likely demonstrating that the objective selected in discovery is being modulated by way of the candidate healing, either in nonclinical and medical studiesWritten by way of a workforce of world-recognized gurus within the box, Ligand-Binding Assays presents key details to a vast variety of practitioners, either within the pharmaceutical and allied industries and in comparable agreement study agencies and educational laboratories and, might be, even within the box of diagnostics and medical chemistry.

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Extra resources for Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena

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A. (1960) Immunoassay of endogenous plasma insulin in man. Journal of Clinical Investigation, 39, 1157–1175. 3. Landsteiner, K. (1945) The Specificity of Serological Reactions. Harvard University Press, Boston, MA (reprinted by Dover, New York, 1962). 4. , and Lieberman, S. (1959) Antigenicity of steroid–protein conjugates. Science, 129, 564–565. 5. W. (1968) The measurement of digitoxin in human serum by radioimmunoassay. Journal of Clinical Investigation, 47, 1035–1042. 6. C. (1976) The radioimmunoassay of drugs: a review.

2007) Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. Journal of Immunological Methods, 321, 1–18. CHAPTER 2 Ligand-Binding Assays to Support Disposition Studies of Macromolecular Therapeutics MARIAN M. KELLEY MKelley Consulting LLC, West Chester, PA, USA MARJORIE A. A. 1 INTRODUCTION Ligand-binding assays (LBAs) have been applied in support of pharmacokinetic (PK) studies for both low molecular weight and macromolecular drug candidates [1,2].

16. , and Perlmann, P. (1971) Enzyme-linked immunosorbent assay (ELISA). Quantitative assay of immunoglobulin G. Immunochemistry, 8, 871–874. 17. M. (1971) Immunoassay using antigen–enzyme conjugates. FEBS Letters, 15, 232–236. 18. F. (1972) “ Homogeneous” enzyme immunoassay. Biochemical and Biophysical Research Communications, 47, 846–851. 19. P. (1995) Time-resolved detection of lanthanide luminescence for ultrasensitive bioanalytical assays. Journal of Photochemistry and Photobiology B, 27, 3–19.

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