369. PrD-LC–MS-IC-SC A bioanalytical method where the analyte protein is purified from the source matrix by an immunoaffinity method and then digested using trypsin or another specific protease, followed by immunoaffinity enrichment of the surrogate peptide from the digest, then quantitative analysis of the surrogate peptide by LC– MS/MS. In specific cases mass spectrometry methods other than MS/MS may be applied.
370. precision The proximity of agreement (i.e., degree of scatter) among a series of measurements obtained from the same homogeneous sample under controlled assay conditions. Precision is defined as (standard deviation/mean) and expressed as a percentage. Three levels are distinguished by the most important validation guidelines:
• Repeatability; •
Intermediate precision; • Reproducibility.
371. preclinical study In vitro and/or in vivo (in animals) evaluation of a medicinal product, procedure or other medical treatment before in-human trials are carried out.
