GBC: Global Bioanalytical Method Validation Consortium
During the panel discussion at the end of the EMEA draft BMV guideline session at the 2nd open symposium held in Barcelona in December 2009 it became adamant that by far the majority of the attendees would favor one global harmonized guidance document on method validation. This wish was acknowledged by the regulators present. First steps towards such a world wide applicable and acceptable document were set in a number of publications in Bioanalysis in April 2010 and further made public and discussed during the CVG workshop on regulated bioanalysis in Montreal in the same month. From there onwards a group is being formed with representatives of various industry BA organisations to foster process towards a global BMV guideline or white paper.
EMA draft guideline on Bioanalytical Method Validation
December 2009 the European Medicines Agency issued her draft guideline on the validation of bioanalytical methods. this guideline is open for consultation and EBF is collecting comments from her member companies.
Next to that we are jointly organising with the EUFEPS a workshop to thoroughly discuss the guideline with all stakeholders. This important meeting will take place in Brussels from 15 to 16 April 2010. For more information on this particular workshop go to the dedicated EBF website or the relevant page on the EUFEPS web.
Dried Blood Spots
Bioanalysis and Dried Blood Spots (DBS) first entered the agenda of EBF in June 2008 and has been repeatedly discussed ever since that first presentation in Basel. There was a full conference session dedicated to DBS during the 2009 open EBF conference in Barcelona and a one and a half day workshop is currently in preparation. For more information on this workshop in Brussels check out EBF's dedicated DBS conference webpages
Incurred Sample Stability
The discussions on ISR automatically also brought stability into view. Proper repeatability / reproducibility testing should not be confounded by effects of any analyte or matrix instability. Testing of incurred sample stability is being put on the agenda of several conferecences recently and it also found its way to the EBF agenda.
There are some indications that changing the anticoagulants counterion, e.g. sodium heparin to lithum heparin, may have some impact on the determination of drug and/or metabolite levels is plasma. EBF is running a survey on this topic among its members. Further a number of members are collecting experimental data.
Anticoagulant of Choice
During the discussions and gathering of experimental information on the influence of anticoagulant counterions on the performance of bioanalytical LC-MS/MS asays it became apperent that some member companies have a strong preference for one type of anticoagulant while it was different for others. Collection and evaluation of data is ongoing.
Definition and quality level: screening <-> qualified <-> validated assay
Ligand Binding Assays: ISR <-> Parallelism
Design of Experiments in LBA
Cut point determination
LBA: curve fitting
Integrated PK/PD analysis
Determination of metabolites (MIST)
Challenges of acylglucuronides analysis
Blood stability / Stability in blood