By their nature, projects requiring formulation work during bioequivalence and scale-up are the very projects that have the most excellent chance of success and are therefore under enormous pressure to make it to market fast. The longer it takes to achieve a bioequivalent formulation or "rescue and repair" a formulation for scale-up, the less time is available for the product to be sold exclusively on the market and to recoup its investment. This profit window will close at a certain point, and the project will have to be written off. The latter can happen at the last minute, sometimes after more than ten years of work and hundreds of millions of investments.
Figure 5
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