Drug Requirements

The amount of bulk drug that is typically required to carry out the non-clinical studies may be a big surprise, in comparison to that needed for initial clinical studies. While many biologically derived drugs may require relatively small quantities, due to the potency of the material or the limited number of non-clinical studies that are possible (see below), a typical program need for 'first time in man' drugs that are relatively non-toxic may require 2-3 kg of active drug. For many companies, this can be difficult from either a manufacturing standpoint (small quantities synthesized prior to scale-up) or cost.

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