治疗药物监测
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◦ requires interpretation of the results, taking into account preanalytical conditions, clinical information and the clinical efficiency of the current dosage regimen; this can involve PK-PD modeling;
It can be based on a prior pharmacogenetic,
demographic and clinical information, and/or on the
a posterior measurement of blood concentrations of
drugs (pharmacokinetic monitoring) and/or biomarkers (pharmacodynamic monitoring)
安徽省立医院药剂科
理论与方法 流程与要点 回顾与展望
定义
◦ 治疗药物监测（Therapeutic Drug Mornitoring， TDM）又称临床药动学监测（clinical pharmacokinetic monitoring, CPM），是指根据药 动学原理，采用现代分析手段，对血液和其他体液中的 药物浓度进行测定并取得有关参数，为临床用药科学化 、个体化、合理化提供依据，从而提高药物疗效，避免 药物中毒反应。 ——《实验诊断学》
Proposed by Standards of Laboratory Practice Committee, 2003
Approved by Executive Committee, 2004 Amended by IATDMCT Executive Committee,
20Hale Waihona Puke Baidu1
-http://www.iatdmct.org/
Therapeutic drug monitoring is defined as “ the measurement made in the laboratory of a parameter that, with appropriate interpretation, will directly influence prescribing procedures ”.
a posteriori TDM:
◦ includes pre-analytical, analytical and post-analytical phases, each with the same importance;
◦ is most often based on the specific, accurate, precise and timely determinations of the active and/or toxic forms of drugs in biological samples collected at the appropriate times in the correct containers (PK monitoring), OR can employ the measurement of biomarkers as a surrogate or end-point markers of effect (PD monitoring) e.g. concentration of an endrogenous compound, enzymatic activity, gene expression, etc. either as a complement to PK monitoring or as the main TDM tool;
a priori TDM:
◦ consists of determining the initial dose regimen to be given to a patient, based on clinical endpoint and on established population pharmacokineticpharmocodynamic (PK/PD) relationships. These relationships help to identify sub-populations of patients with different dosage requirements, by utilizing demographic data, clinical findings, clinical chemistry results, and/or, when appropriate, pharmacogenetic characteristics.
TDM is a multi-disciplinary clinical specialty aimed at improving patient care by individually adjusting the dose of drugs for which clinical experience or clinical trials have shown it improved outcome in the general or special populations.
Commonly the measurement is in a biologic matrix of a prescribed xenobiotic, but it may also be of an endogenous compound prescribed as replacement therapy in an individual who is physiologically or pathologically deficient in that compound
It can be based on a prior pharmacogenetic,
demographic and clinical information, and/or on the
a posterior measurement of blood concentrations of
drugs (pharmacokinetic monitoring) and/or biomarkers (pharmacodynamic monitoring)
安徽省立医院药剂科
理论与方法 流程与要点 回顾与展望
定义
◦ 治疗药物监测（Therapeutic Drug Mornitoring， TDM）又称临床药动学监测（clinical pharmacokinetic monitoring, CPM），是指根据药 动学原理，采用现代分析手段，对血液和其他体液中的 药物浓度进行测定并取得有关参数，为临床用药科学化 、个体化、合理化提供依据，从而提高药物疗效，避免 药物中毒反应。 ——《实验诊断学》
Proposed by Standards of Laboratory Practice Committee, 2003
Approved by Executive Committee, 2004 Amended by IATDMCT Executive Committee,
20Hale Waihona Puke Baidu1
-http://www.iatdmct.org/
Therapeutic drug monitoring is defined as “ the measurement made in the laboratory of a parameter that, with appropriate interpretation, will directly influence prescribing procedures ”.
a posteriori TDM:
◦ includes pre-analytical, analytical and post-analytical phases, each with the same importance;
◦ is most often based on the specific, accurate, precise and timely determinations of the active and/or toxic forms of drugs in biological samples collected at the appropriate times in the correct containers (PK monitoring), OR can employ the measurement of biomarkers as a surrogate or end-point markers of effect (PD monitoring) e.g. concentration of an endrogenous compound, enzymatic activity, gene expression, etc. either as a complement to PK monitoring or as the main TDM tool;
a priori TDM:
◦ consists of determining the initial dose regimen to be given to a patient, based on clinical endpoint and on established population pharmacokineticpharmocodynamic (PK/PD) relationships. These relationships help to identify sub-populations of patients with different dosage requirements, by utilizing demographic data, clinical findings, clinical chemistry results, and/or, when appropriate, pharmacogenetic characteristics.
TDM is a multi-disciplinary clinical specialty aimed at improving patient care by individually adjusting the dose of drugs for which clinical experience or clinical trials have shown it improved outcome in the general or special populations.
Commonly the measurement is in a biologic matrix of a prescribed xenobiotic, but it may also be of an endogenous compound prescribed as replacement therapy in an individual who is physiologically or pathologically deficient in that compound