TY - RPRT TI - Beyond accuracy, precision and TAE: Direct assay validation against product specification aligned with USP <1033> AU - Josipovic, D. PY - 2025 DO - 10.1101/2025.05.21.655192 UR - https://www.biorxiv.org/content/10.1101/2025.05.21.655192v1 ID - 10.1101/2025.05.21.655192 ER -