A Quantitative Structure–Activity Relationship for Translocation of Tripeptides via the Human Proton-Coupled Peptide Transporter, hPEPT1 (SLC15A1) Journal title: The AAPS Journal Authors: Diana Højmark Omkvist, Simon Birksø Larsen, Carsten Uhd Nielsen, Bente Steffansen, L... Subject(s): Medicine
Ligand-Binding Mass Spectrometry to Study Biotransformation of Fusion Protein Drugs and Guide Immunoassay Development: Strategic Approach and Application to Peptibodies Targeting the Thrombopoietin Receptor Journal title: The AAPS Journal Authors: Michael P. Hall, Colin Gegg, Kenneth Walker, Christopher Spahr, Robert Ortiz, Vimal Patel, Steven Yu... Subject(s): Medicine
“Fit-for-Purpose” Method Validation and Application of a Biomarker (C-terminal Telopeptides of Type 1 Collagen) in Denosumab Clinical Studies Journal title: The AAPS Journal Authors: Jin Wang, Jean Lee, Daniel Burns, David Doherty, Laura Brunner, Mark Peterson, Binodh DeSilva Subject(s): Medicine
Development, Validation, and Clinical Implementation of an Assay to Measure Total Antibody Response to Naglazyme® (Galsulfase) Journal title: The AAPS Journal Authors: Joleen T. White, Lisa Argento Martell, Andrea Van Tuyl, Ryan Boyer, Laura Warness, Gary T. Taniguchi... Subject(s): Medicine
Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples Journal title: The AAPS Journal Authors: William Nowatzke, Eric Woolf Subject(s): Medicine
Critical ligand binding reagent preparation/selection: When specificity depends on reagents Journal title: The AAPS Journal Authors: Bonita Rup, Denise O'Hara Subject(s): Medicine
Key elements of bioanalytical method validation for macromolecules Journal title: The AAPS Journal Authors: Marian Kelley, Binodh DeSilva Subject(s): Medicine
Specificity and selectivity evaluations of ligand binding assay of protein therapeutics against concomitant drugs and related endogenous proteins Journal title: The AAPS Journal Authors: Jean Lee, Hongjin Ma Subject(s): Medicine
Appropriate calibration curve fitting in ligand binding assays Journal title: The AAPS Journal Authors: John W. A. Findlay, Robert F. Dillard Subject(s): Medicine
Confirmatory reanalysis of incurred bioanalytical samples Journal title: The AAPS Journal Authors: Mario L. Rocci, Viswanath Devanarayan, David B. Haughey, Paula Jardieu Subject(s): Medicine
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 Journal title: The AAPS Journal Authors: Eric J. Woolf, Stuart McDougall, Douglas M. Fast, Maristela Andraus, Matthew Barfield, Michael Black... Subject(s): Medicine
Development of a Method That Eliminates False-Positive Results due to Nerve Growth Factor Interference in the Assessment of Fulranumab Immunogenicity Journal title: The AAPS Journal Authors: Sheng Dai, Allen Schantz, Adrienne Clements-Egan, Michael Cannon, Gopi Shankar Subject(s): Medicine
Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team Journal title: The AAPS Journal Authors: Lindsay E. King, Esme Farley, Mami Imazato, Jeannine Keefe, Masood Khan, Mark Ma, K. Susanne Pihl, P... Subject(s): Medicine
When Assay Format Matters: a Case Study on the Evaluation of Three Assay Formats to Support a Clinical Pharmacokinetic Study Journal title: The AAPS Journal Authors: Kun Peng, Dana Baker, Suzanne Brignoli, Janis Cabuhat, Saloumeh K. Fischer Subject(s): Medicine
Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments Journal title: The AAPS Journal Authors: Joseph C. Marini, Michael Anderson, Xiao-Yan Cai, John Chappell, Todd Coffey, Dominique Gouty, Aparn... Subject(s): Medicine
