Biomarkers method transfer

The ISO protocol for the biochemical response EROD (ISO 23893-2/AWI) as a recent example of a bioanalytical (biomarker) [49,50] method standardised under ISO for fish needs harmonisation with the other test systems and between the laboratories (users) before implementation. Use of biomarkers (biochemical responses) in multi-arrays for environmental monitoring according to Hansen et al. [50] is complementary to chemical analysis since they can alert for the presence of ecotoxic compounds. Bringing into the WFD, the effect-related approaches concerning bioassays and biomarkers are only relevant in the context of the QN of environmental relevant substances and the good chemical status. But it is rather difficult to transfer the monitored biochemical responses or biomarkers into an operational effect-related standard. They serve as the basis for environmental protection against hazardous substances. In relation to... 

Close co-operation for a year or more before the first administration to humans is likely to lead to a smooth transfer of the compound and the rapid movement of a compound out of preclinical into man. This lead time can be used to devise the ED plan, design the first studies and, when appropriate, to select and develop methodologies which will contribute to the drug s evaluation in man. This may include validation of pharmacodynamic measures to be used in the clinical pharmacology unit, assessment of various imaging techniques, development of bioanalytical methods for biomarkers, the drug and metabolites. Not infrequently, the assays that were perfectly adequate to support preclinical work are insufficiently sensitive, specific or accurate to quantify the comparatively low concentrations in humans. At the very least, assays require validation in human plasma and urine. 

---