Ligand-binding assays: development, validation, and implementation in the drug development arena

Although unofficial regulatory guidance has been available since 1992 (in theform of Crystal City Conference proceedings) for validation of chromatographic bioanalytical methods (primarily mass spectrometry-based hyphenated techniques), little guidance has been available for LBA validation, particularly for assays used to support macromolecule drug development. With increasing use of LBAs in the pharmaceutical industry, the need to critically evaluate technical and regulatory issues related to the use of these technologies in the GLP environment has increased greatly in the last decade. This book fills that void and provides a reference text covering critical aspects of the development, validation, and implementation of ligand binding assays in the drug development field. Coverage in the book includes: pharmacokinetic studies, development of LBAs, assay validation, statistical LBA aspects, regulatory aspects, software for LBAs, and robotics and other emerging methodologies for LBAs.

• ISBN: 978-0-470-04138-3
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 424
• Fecha Publicación: 24/11/2009
• Nº Volúmenes: 1
• Idioma: Inglés