Preclinical development
A selected candidate drug identified in the drug discovery process has promising potential to interfere with disease progression by acting on a specific target that is important for the disease in question. Nevertheless, more information is needed on the ADME properties of the compound, and its potential benefits, risks and mechanisms of action. Preclinical development must also provide detailed information on its pharmacokinetic properties as well as on dosing and administration schemes together with possible formulations. In addition, regulatory non-clinical toxicological testing is required for risk assessment and management before the drug can be investigated in humans. The manufacturing process has to be scaled up in a GMP-compatible environment to produce sufficient quantities of the drug for both non-clinical regulatory tests and for forthcoming clinical trials.
