Method Transfer, Partial Validation, and Cross Validation: Recommendations for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team Journal title: The AAPS Journal Authors: R. J. Briggs, R. Nicholson, F. Vazvaei, J. Busch, M. Mabuchi, K. S. Mahesh, M. Brudny-Kloeppel, N. W... 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
Retrospective Data Analysis and Proposal of a Practical Acceptance Criterion for Inter-laboratory Cross-validation of Bioanalytical Methods Using Liquid Chromatography/Tandem Mass Spectrometry Journal title: The AAPS Journal Authors: Tomoki Yoneyama, Takashi Kudo, Fumihiro Jinno, Eric R. Schmidt, Takahiro Kondo Subject(s): Medicine
QbD-Driven Development and Validation of a Bioanalytical LC–MS Method for Quantification of Paliperidone in Human Plasma Journal title: International Journal of Experimental Research and Review Authors: Jagirdar Sikandar Zoolquernain Farooq, Furquan Nazimuddin Khan Subject(s): Cattle, Dairy processing. Dairy products, Biological Sciences, Chemistry, Computer and Information Science, Mathematics, Miscellaneous, Medical Education
