PET as a Tracer Method in Drug Development

The development of new drugs is a time consuming and expensive process. The costs are markedly increased the closer the drug proceeds towards market approval. This is especially clear when the process has reached the phase of clinical trials. During drug development a number of decisions have to be taken. At each point, adequate information must be available to give an optimal base for decision. The relevance of pre-

Figure 10.8. Synthesis of [21-11C]-progesterone and [1a-methyl-11C]-mesterolone.

Figure 10.8. Synthesis of [21-11C]-progesterone and [1a-methyl-11C]-mesterolone.

11CO

Figure 10.9. Palladium- and selenium-mediated carbonylations.

clinical studies (for example, in genetically modified cells or small animals) for the drug behavior in man is a key issues in the phase I and phase II clinical trials. PET combined with in vitro studies may bridge the gap between specific biology in cell and tissue and the complicated, integrated biology in man. PET is thus increasingly applied in different areas of drug development for these reasons. The possibility to label drug candidates with nC for preclinical and early human PET studies (for example, phase I) may have significant impact on the choice of lead compound as well as on selection of dose and dose level in subsequent clinical trial.

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