1TH
ROUND 2008 OF THE INTERNATIONAL QUALITY CONTROL PROGRAM
FOR ANTIFUNGAL DRUGS
Preface
Dear
Participant,
Here
are the results of your participation in the 1st Round 2008 of the
International Interlaboratory Quality Control Program for Therapeutic Drug
Monitoring of Azole Antifungals. This report is a summary of the results you
reported.
Samples
were prepared by weighing the required amount of the different analytes and
adding them to human plasma. This plasma has been obtained from healthy
volunteers.
All azole antifungal drugs
were obtained from pharmaceutical industries and had a very high (>99%) and
specified purity. All weighed in concentrations were considered true values.
Samples were analyzed with our own validated high performance liquid
chromatography (HPLC) as a confirmative check (less than 5% deviation from true
concentration) before the samples were released for the QC program. All
samples were shipped at ambient temperature.
Participating
laboratories were asked to measure the concentration of the antifungal drugs and
report the results. The objectives of this 1st Round were to identify
sources of error in bioanalytical methods, to contribute to the optimisation of
the bioanalysis of antiretroviral drugs and to establish interconvertibility of
analytical results among laboratories and methods.
Each
concentration within the range 80-120 % was considered “OK”, while results
outside the 80-120% range were termed ‘not OK’.
July
2008, KKGT office