Development of Tests to Measure Medicines in the Body
Research type
Research Study
Full title
Validation of Drug Assays in Various Biological Matrices
IRAS ID
105811
Contact name
Saye H Khoo
Contact email
Research summary
The main aim of this research is to ensure that tests that measure drugs including antimicrobials (such as antibiotics), antivirals, oral contraceptives (i.e. the pill) and erectile dysfunction agents in various bodily fluids are doing so accurately and that the tests are working properly. Drug concentrations are commonly measured in blood or plasma using a process called high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS), but it is often necessary to measure the amount of drug in other compartments such as urine, saliva or spinal fluid in order to determine how drugs distribute in the body and also to help understand how diseases which effect different parts of the body are treated. Clinical trials will often require measurement of drugs in the body in order to determine whether the medications will be of benefit to patients and the dose is correct. Therefore it is important that the tests are working properly and able to detect and quantify a wide range of concentrations that may be experienced by patients (both low and high concentrations). These tests are also essential to help establish how drugs affect each other if they are to be given together, i.e. investigate drug-drug interactions.
In order to make sure these tests are working correctly and able to measure drugs in different bodily fluids, samples of blood, urine, saliva and spinal fluid need to be taken from individuals receiving drugs including antimicrobials, antivirals, oral contraceptives and erectile dysfunction agents. Furthermore samples from individuals not receiving these medications are needed for quality control purposes and will have the drug added to the sample after it has been taken.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/1097
Date of REC Opinion
23 Jul 2014
REC opinion
Favourable Opinion