T/CITS 178-2024 Neuropsychiatric drug treatment medication monitoring project analysis quality objectives Part 1: 19 drugs or metabolites including chlorzepate
T/CITS 178-2024 Neuropsychiatric drug treatment medication monitoring project analysis quality objectives Part 1: 19 drugs or metabolites including chlorzepate
Basic Information
Scope
Scope: This document specifies the analytical quality objectives and applications of therapeutic drug monitoring (TDM) programs for 19 neuropsychiatric drugs or metabolites. This document is applicable to clinical laboratories, interlaboratory quality evaluation institutions, third-party testing institutions, instrument or reagent manufacturers, and other activities related to TDM project internal quality control, external quality evaluation, and method performance confirmation and validation. Main technical content: Foreword Introduction 1 Scope 2 Normative reference documents 3 Terms and definitions 4 Analysis quality requirements setting 4.1 Setting principles 4.2 Setting indicators 5 Indicator applications 5.1 Intra-laboratory quality control 5.2 Interlaboratory quality evaluation 5.3 Performance verification and confirmation References