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Defining the relevant Pharmacokinetic (PK) and Pharmacodynamic (PD) endpoints for each drug-candidate mandates repeated blood sampling, as well as tumour and normal tissue sampling. The need for the development of non-invasive techniques that will enable us to closely monitor what the body does to the drug and also, what the drug does to the body is becoming essential. Functional and molecular imaging techniques are constantly gaining recognition as useful non-invasive tools that can provide significant direct and indirect information regarding both PK and PD endpoints.