Workshop on Bioanalytical Methods Validation for Macromolecules: Summary Report

@article{Miller2001WorkshopOB,
  title={Workshop on Bioanalytical Methods Validation for Macromolecules: Summary Report},
  author={Krys J. Miller and Ronald R Bowsher and Abbie Cheryl Celniker and Jacqueline A. Gibbons and Shalini Gupta and Jean Wenqing. Lee and Steve J. Swanson and Wendell Carl Smith and Russell S. Weiner and Daan J A Crommelin and Indra J. Das and Binodh S. DeSilva and Robert F. Dillard and Michael Geier and Han C Gunn and M. D. Faseeulla Khan and Dean W. Knuth and Michael G. Kunitani and Gerald D. Nordblom and Ren{\'e} J. A. Paulussen and Jeffrey M. Sailstad and Richard L. Tacey and Ann Y. Watson},
  journal={Pharmaceutical Research},
  year={2001},
  volume={18},
  pages={1373-1383}
}
1. To determine industry and regulatory standards established for bioanalytical method validation in support of the estimation and characterization of macromolecules in the preclinical and clinical stages of drug development. 2. To evaluate special validation considerations for quantitative, macromolecule-detecting technologies that have emerged since 1990 including immunoassays, cell-based assays, antibody titers, and automation in the laboratory. 3. To address the strengths/limitations and… CONTINUE READING
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