共 50 条
- [31] Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team AAPS JOURNAL, 2014, 16 (06): : 1167 - 1174
- [32] AN APPROACH TO BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION: A REVIEW INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES AND RESEARCH, 2016, 7 (06):
- [33] Key elements of bioanalytical method validation for macromolecules AAPS JOURNAL, 2007, 9 (02): : E156 - E163
- [37] Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance The AAPS Journal, 2015, 17 : 277 - 288
- [38] Retrospective Analysis of Bioanalytical Method Validation Approaches in Biosimilar Biological Product Development AAPS JOURNAL, 2019, 21 (06):
- [40] METHOD VALIDATION - THE HARMONIZATION OF COLLABORATIVE ANALYTICAL STUDIES JOURNAL OF THE ASSOCIATION OF OFFICIAL ANALYTICAL CHEMISTS, 1986, 69 (03): : 392 - 392