%0 Journal Article %1 DeSilva.2003 %A DeSilva, B. %A Smith, W. %A Weiner, R. %A Kelley, M. %A Smolec, J. %A Lee, B. %A Khan, M. %A Tacey, R. %A Hill, H. %A Celniker, A. %D 2003 %J Pharm.Res. %K Assay Binding Carrier Europe Ligands Macromolecular Pharmaceutical Preparations Proteins Radioligand Reproducibility Research Results States Substances United metabolism methods of protein standards %N 11 %P 1885-1900 %T Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules %U PM:14661937 %V 20 %X PURPOSE: With this publication a subcommittee of the AAPS Ligand Binding Assay Bioanalytical Focus Group (LBABFG) makes recommendations for the development, validation, and implementation of ligand binding assays (LBAs) that are intended to support pharmacokinetic and toxicokinetic assessments of macromolecules. METHODS: This subcommittee was comprised of 10 members representing Pharmaceutical, Biotechnology, and the contract research organization industries from the United States, Canada, and Europe. Each section of this consensus document addresses a specific analytical performance characteristic or aspect for validation of a LBA. Within each section the topics are organized by an assay's life cycle, the development phase, pre-study validation, and in-study validation. Because unique issues often accompany bioanalytical assays for macromolecules, this document should be viewed as a guide for designing and conducting the validation of ligand binding assays. RESULTS: Values of +/- 20%

@article{DeSilva.2003, abstract = {PURPOSE: With this publication a subcommittee of the AAPS Ligand Binding Assay Bioanalytical Focus Group (LBABFG) makes recommendations for the development, validation, and implementation of ligand binding assays (LBAs) that are intended to support pharmacokinetic and toxicokinetic assessments of macromolecules. METHODS: This subcommittee was comprised of 10 members representing Pharmaceutical, Biotechnology, and the contract research organization industries from the United States, Canada, and Europe. Each section of this consensus document addresses a specific analytical performance characteristic or aspect for validation of a LBA. Within each section the topics are organized by an assay's life cycle, the development phase, pre-study validation, and in-study validation. Because unique issues often accompany bioanalytical assays for macromolecules, this document should be viewed as a guide for designing and conducting the validation of ligand binding assays. RESULTS: Values of +/- 20% }, added-at = {2010-02-05T11:28:39.000+0100}, author = {DeSilva, B. and Smith, W. and Weiner, R. and Kelley, M. and Smolec, J. and Lee, B. and Khan, M. and Tacey, R. and Hill, H. and Celniker, A.}, biburl = {https://www.bibsonomy.org/bibtex/2f16db2e909b938f8cb79173883553386/kanefendt}, interhash = {8775a2d00c7f638feff1a8bdc13dbaec}, intrahash = {f16db2e909b938f8cb79173883553386}, journal = {Pharm.Res.}, keywords = {Assay Binding Carrier Europe Ligands Macromolecular Pharmaceutical Preparations Proteins Radioligand Reproducibility Research Results States Substances United metabolism methods of protein standards}, number = 11, pages = {1885-1900}, timestamp = {2010-02-05T11:28:40.000+0100}, title = {Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules}, url = {PM:14661937}, volume = 20, year = 2003 }