highly significantp < 0.01
Reliability of the Assay Results The Chinese Pharmacopoeia (2025 Edition), Volume IV, General Chapter 1431 “Statistical Methods for Biological Assays” specifies the requirements for each variation term in reliability tests: the regression term must be highly significant ( p < 0.01), R 2 must be ≥ 0.98, and the deviation from parallelism must be non-significant ( p ≥ 0.05) [ 22 ].