Pharmacodynamics imaging techniques

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. 

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