Theme: Best Practices for Bioanalytical Methods: Recommendations from the Global Bioanalysis Consortium

In this topical collection (15 articles)

1. 

   Commentary

   Tiered Approaches to Chromatographic Bioanalytical Method Performance Evaluation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

   S. Lowes, R. Hucker, M. Jemal, J. C. Marini, V. M. Rezende, R. Shoup… Pages 17-23

2. 

   White Paper

   Large Molecule Specific Assay Operation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

   Lauren Stevenson, Marian Kelley, Boris Gorovits, Clare Kingsley… Pages 83-88

3. 

   Brief/Technical Note

   Automation Practices in Large Molecule Bioanalysis: Recommendations from Group L5 of the Global Bioanalytical Consortium

   Ago Ahene, Claudio Calonder, Scott Davis, Joseph Kowalchick… Pages 164-171

4. 

   Review Article

   Assay Formats: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

   Sherri Dudal, Daniel Baltrukonis, Rebecca Crisino, M. Jaya Goyal… Pages 194-205

5. 

   White Paper

   Large Molecule Run Acceptance: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

   Marian Kelley, Christopher Beaver, Lauren F. Stevenson, Ross Bamford… Pages 221-225

6. 

   Brief/Technical Note

   Recommendations from the Global Bioanalysis Consortium Team A8: Documentation

   Tom Verhaeghe, Hollie H. Barton, Hisanori Hara, Richard Hucker… Pages 240-245

7. 

   Commentary

   Recommendations and Best Practices for Reference Standards and Reagents Used in Bioanalytical Method Validation

   Joseph F. Bower, Jennifer B. McClung, Carl Watson, Takahiko Osumi… Pages 352-356

8. 

   Commentary

   New Frontiers—Accelerator Mass Spectrometry (AMS): Recommendation for Best Practices and Harmonization from Global Bioanalysis Consortium Harmonization Team

   Graeme C. Young, Mark Seymour, Stephen R. Dueker, Philip Timmerman… Pages 357-359

9. 

   Review Article

   Stability: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

   Nico van de Merbel, Natasha Savoie, Manish Yadav, Yoshiaki Ohtsu… Pages 392-399

10. 

    White Paper

    A White Paper—Consensus and Recommendations of a Global Harmonization Team on Assessing the Impact of Immunogenicity on Pharmacokinetic Measurements

    J. M. Sailstad, L. Amaravadi, A. Clements-Egan, B. Gorovits… Pages 488-498

11. 

    White Paper

    Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team

    Lindsay E. King, Esme Farley, Mami Imazato, Jeannine Keefe, Masood Khan… Pages 504-515

12. 

    White Paper

    Small Molecule Specific Run Acceptance, Specific Assay Operation, and Chromatographic Run Quality Assessment: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Teams

    Eric J. Woolf, Stuart McDougall, Douglas M. Fast, Maristela Andraus… Pages 885-893

13. 

    White Paper

    Method Transfer, Partial Validation, and Cross Validation: Recommendations for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

    R. J. Briggs, R. Nicholson, F. Vazvaei, J. Busch, M. Mabuchi… Pages 1143-1148

14. 

    Editorial

    Introduction to the Proposals from the Global Bioanalysis Consortium Harmonization Team

    Philip Timmerman, Mark Arnold, Binodh DeSilva, Fabio Garofolo… Pages 1159-1161

15. 

    Review Article

    Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

    Eric Fluhler, Faye Vazvaei, Puran Singhal, Petra Vinck, Wenkui Li… Pages 1167-1174