A Tiered Approach for Characterization to Ensure Quality, Reproducibility, and Long-Term Stability of Critical Reagents in Regulated Bioanalysis to Support PK/ADA/NAb Assays for Biologics and Vaccines Programs.
ACS Pharmacology & Translational Science（2020）
关键词
regulated bioanalysis,PK/ADA/Nab,critical reagents,tiered approach,characterization,biologics and vaccines
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