No CrossRef data available.
Article contents
Dose-related Reference Ranges for Therapeutic Drug Monitoring in Human Blood Specimens
Published online by Cambridge University Press: 16 April 2020
Abstract
A dose related reference range is calculated as a concentration range within that a drug concentration has to be expected in human blood specimens under medication with a given dose of the drug. The calculation is based on the direct correlation of the drug dose De (constant dose under long term therapy) to its blood concentration c with the total clearance of the drug (Clt) being the correlation coefficient (De = D / t = c × Clt). The clearance is taken as arithmetic mean ± standard deviation from phase II clinical trials of the drug. Thus the dose related reference range will statistically contain 68,27 % of all the drug concentrations determined under normal condition in the blood of a normal patient, where “normal” is defined as the patient population in the respective phase II clinical trial. It usually consists of patients 18-65 years of age without relevant comorbidity, comedication, and genetic abnormalities in drug metabolism. Therefore, any drug concentration determined outside its dose-related reference range creates a signal to alert for individual abnormalities in a patient such as drug-drug-interactions, gene polymorphisms that give rise to slow/rapid metabolizers, altered function of the excretion organs liver and kidneys by age and/or disease, compliance problems, a missing pharmacokinetic steady state and even signal overlay in the laboratory analysis. A table listing factors that allows the calculation of dose-related reference ranges for all relevant psychopharmaca will be included in the first update of the TDM consensus guideline to be published in Pharmacopsychiatry.
- Type
- S20-04
- Information
- European Psychiatry , Volume 24 , Issue S1: 17th EPA Congress - Lisbon, Portugal, January 2009, Abstract book , January 2009 , 24-E109
- Copyright
- Copyright © European Psychiatric Association 2009
Comments
No Comments have been published for this article.