%0 Journal Article %1 Smolec.2005 %A Smolec, J. %A DeSilva, B. %A Smith, W. %A Weiner, R. %A Kelly, M. %A Lee, B. %A Khan, M. %A Tacey, R. %A Hill, H. %A Celniker, A. %A Shah, V. %A Bowsher, R. %A Mire-Sluis, A. %A Findlay, J. W. %A Saltarelli, M. %A Quarmby, V. %A Lansky, D. %A Dillard, R. %A Ullmann, M. %A Keller, S. %A Karnes, H. T. %D 2005 %J Pharm.Res. %K Analytical Binding Calibration Chemistry Laboratories Pharmacokinetics Reference Reproducibility Results Sensitivity Specificity Standards and methods of %N 9 %P 1425-1431 %T Bioanalytical method validation for macromolecules in support of pharmacokinetic studies %U PM:16132353 %V 22 %X The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report of the workshop from 2003 focuses on the issues discussed in presentations and notes points of discussion and areas of consensus among the participants

@article{Smolec.2005, abstract = {The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report of the workshop from 2003 focuses on the issues discussed in presentations and notes points of discussion and areas of consensus among the participants}, added-at = {2010-02-05T11:28:39.000+0100}, author = {Smolec, J. and DeSilva, B. and Smith, W. and Weiner, R. and Kelly, M. and Lee, B. and Khan, M. and Tacey, R. and Hill, H. and Celniker, A. and Shah, V. and Bowsher, R. and Mire-Sluis, A. and Findlay, J. W. and Saltarelli, M. and Quarmby, V. and Lansky, D. and Dillard, R. and Ullmann, M. and Keller, S. and Karnes, H. T.}, biburl = {https://www.bibsonomy.org/bibtex/2ea93202a08fd8c0d6aa5a7f471006d74/kanefendt}, interhash = {80689393b2c9e2f1ef2c275585d570e9}, intrahash = {ea93202a08fd8c0d6aa5a7f471006d74}, journal = {Pharm.Res.}, keywords = {Analytical Binding Calibration Chemistry Laboratories Pharmacokinetics Reference Reproducibility Results Sensitivity Specificity Standards and methods of}, number = 9, pages = {1425-1431}, timestamp = {2010-02-05T11:28:43.000+0100}, title = {Bioanalytical method validation for macromolecules in support of pharmacokinetic studies}, url = {PM:16132353}, volume = 22, year = 2005 }