PMID- 22851358
OWN - NLM
STAT- MEDLINE
DCOM- 20121203
LR  - 20160511
IS  - 1942-7611 (Electronic)
IS  - 1942-7603 (Linking)
VI  - 4 Suppl 1
DP  - 2012 Aug
TI  - Application of EU guidelines for the validation of screening methods for 
      veterinary drugs.
PG  - 28-33
LID - 10.1002/dta.1357 [doi]
AB  - Commission Decision (CD) 2002/657/EC describes detailed rules for method 
      validation within the framework of residue monitoring programmes. The approach 
      described in this CD is based on criteria. For (qualitative) screening methods, 
      the most important criteria is that the CCbeta has to be below any regulatory limit. 
      Especially when microbiological or immunochemical methods are involved, the 
      approach described in the CD is not easily applied. For example, by those 
      methods, a large number of analytes (all antibiotics) within several different 
      matrices (meat, milk, fish, eggs, etc.) are detected. It is not completely clear 
      whether all those analytes and all matrices have to be taken into account during 
      method validation. To clarify this, a working group - from EU Reference 
      Laboratories - came up with a practical approach to validate multi-analyte 
      multi-matrix screening methods. It describes how many analyte/matrix combinations 
      have to be tested and how these combinations are selected. Furthermore it 
      describes how to determine CCbeta for screening methods in relation to a large list 
      of compounds and maximum residue limits (MRLs). First for each analyte/matrix 
      combination the 'cut-off' level - i.e. the level at which the method separates 
      blanks from contaminated samples - is established. The validation is preferably 
      at the concentration of 50% of the regulatory limit. A minimum set of 20 
      different samples has to be tested. From the experiences with applying these 
      guidelines it was concluded that the validation approach is very 'practical'; 
      however, there are some remarks. One has to be careful with selecting 
      'representative' analytes and matrices and it is strongly recommended to collect 
      additional validation data during the routine application of the method.
CI  - (c) 2012 RIKILT-Wageningen University and Research. Drug Testing and Analysis (c) 
      2012 John Wiley & Sons, Ltd.
FAU - Stolker, Alida A M Linda
AU  - Stolker AA
AD  - RIKILT -Wageningen University and Research Centre, Wageningen, the Netherlands. 
      linda.stolker@wur.nl
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Drug Test Anal
JT  - Drug testing and analysis
JID - 101483449
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Coccidiostats)
RN  - 0 (Veterinary Drugs)
RN  - 66974FR9Q1 (Chloramphenicol)
SB  - IM
MH  - Animals
MH  - Anti-Bacterial Agents/*analysis
MH  - Chloramphenicol/*analysis
MH  - Coccidiostats/*analysis
MH  - European Union
MH  - Flow Cytometry/methods/standards
MH  - Food Analysis/methods/*standards
MH  - Immunoenzyme Techniques/methods/standards
MH  - Mass Spectrometry/methods/standards
MH  - *Validation Studies as Topic
MH  - Veterinary Drugs/*analysis
EDAT- 2012/08/08 06:00
MHDA- 2012/12/10 06:00
CRDT- 2012/08/02 06:00
PHST- 2012/08/02 06:00 [entrez]
PHST- 2012/08/08 06:00 [pubmed]
PHST- 2012/12/10 06:00 [medline]
AID - 10.1002/dta.1357 [doi]
PST - ppublish
SO  - Drug Test Anal. 2012 Aug;4 Suppl 1:28-33. doi: 10.1002/dta.1357.