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Drug doses are often titrated upon their clinical effects (e.g., blood pressure). Unfortunately, for many drugs there is no direct, clinical read-out to estimate dose adequateness. Alternatively, drug dosing is based on the maximum tolerated dose approach or therapeutic drug monitoring. However, the concentration-response curves may be flattened or bell-shaped as suggested for some 'biologicals'. Together, these aspects raise the question why drug dosing is not individualized by pharmacodynamic monitoring. Evaluating the effects of drugs at their pharmacological target or meaningful biomarkers might indicate nonresponders, objectively quantify the maximum molecular effect and thus restrict overdose and underdosing. This review outlines the theory and biological or technical prerequisites for biomarker-based pharmacodynamic monitoring, and highlights selected examples from different fields of clinical medicine.
This article was published in the following journal.
Name: Biomarkers in medicine
Pharmacodynamic monitoring may complement routine pharmacokinetic monitoring of mTOR inhibitors (mTORi) in an attempt to better guide individualized sirolimus (SRL) or everolimus (EVR) treatment after...
To define pharmacodynamic and efficacy biomarkers in ulcerative colitis [UC] patients treated with PF-00547659, an anti-human mucosal addressin cell adhesion molecule-1 [MAdCAM-1] monoclonal antibody,...
Eculizumab is the first drug approved for the treatment of complement-mediated diseases, and current dosage schedules result in large interindividual drug concentrations. This review provides insight ...
Rheumatoid arthritis (RA) is an autoimmune disease in which autoantibodies attack the synovial membrane, causing joint inflammation. Blood tests would offer a powerful, minimally invasive method for e...
This study will identify baseline and/or pharmacodynamic biomarkers of response to ruxolitinib, based upon association with quantitative change in tumor size following 14-21 days of neoadj...
The aim of the study is to investigate and explore the most important aspects of drug-adherence in the treatment of hypertension in order to improve treatment and blood pressure control, i...
The investigators want to compare the performance of anesthetic depth monitoring for sedation (ADMS) to the bispectral index (BIS) as electroencephalographic measures of sevoflurane effect...
A Phase I, Randomized, Placebo-controlled, Double Blind, Repeat Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Gastrointestinal Transit Time and Pharmacodynamic Biomarkers of GSK3179106 in Normal Subjects
The current study is designed to assess the safety, tolerability, pharmacokinetics (PK), gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses of GSK3...
The objective of this randomized controlled trial (RCT) is to evaluate whether the Systematic Tool to Reduce Inappropriate Prescribing (STRIP), put into practice through the STRIP Assistan...
Measurable biological parameters that serve for drug development, safety and dosing (DRUG MONITORING).
A factor associated with the well-being of living organisms that is used as a measure of environmental change and or influence. For example, aldehyde dehydrogenase expression in earthworm tissue is used as an indication of heavy metal pollution in soils. Distinguish from BIOMARKERS.
Physiologic or biochemical monitoring of the fetus. It is usually done during LABOR, OBSTETRIC and may be performed in conjunction with the monitoring of uterine activity. It may also be performed prenatally as when the mother is undergoing surgery.
Molecular products metabolized and secreted by neoplastic tissue and characterized biochemically in cells or BODY FLUIDS. They are indicators of tumor stage and grade as well as useful for monitoring responses to treatment and predicting recurrence. Many chemical groups are represented including HORMONES; ANTIGENS; amino and NUCLEIC ACIDS; ENZYMES; POLYAMINES; and specific CELL MEMBRANE PROTEINS and LIPIDS.
A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion.
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...