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In the course of the development of a new drug, the selection of the most promising molecule from a series of closely related molecules for further development is timeconsuming and expensive. Data provided by pharmacodynamic studies conducted in vitro or in vivo, or by pharmacological studies in test animals, are often inadequate to differentiate with sufficient reliability those molecules which should be excluded from further development. When considering start-up and smaller companies in particular, it is extremely important to focus as early as possible on the most promising candidate for further development, in order to save time, resources and costs.
In such a case, it must be emphasised that the most reliable information about a drug can really only be generated using human subjects (volunteers or patients). The results obtained when going first time in man are therefore of pivotal relevance, and enable a sponsor to get a much more accurate picture of the pharmacological potential of a molecule. |
