The drug

The ideal candidate will have potent activity against its target (e.g. VEGF receptor tyrosine kinase), minimal against other targets, be water soluble, and be physically and chemically stable both in powder form and in solution. The specification should ensure the material is of adequate quality and conforms to current requirements (i.e. ICH guidelines). Methods should be developed with indicate stability and will detect and quantify, with sufficient sensitivity and accuracy, the drug, its degradation products, and the intermediates involved in its synthesis.

Ideally, several batches should be made to confirm that the synthetic route is robust and that consistency of material with respect to purity of drug substance and levels of contaminants (including solvents, synthetic intermediates, and degradation products) can be achieved. However, if several batches are not to be made, the batch produced initially should be large enough for all preclinical testing and early clinical trials.

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