7.4. Is there a return on investment (ROI) for QbD

The final question tries to investigate the perceived ROI companies have experienced from the roll out of QbD and is thus closely connected to the fulfilment of initial expectations. However, the focus here is really on whether and how the company has measured or plans to measure such a ROI for the investments it had to make for the roll out.

Calculating ROI as net profit before taxes divided by the investment⁷² to measure the managerial effectiveness and efficiency of an investment is obviously not possible in a straight forward way for QbD. As the net profit before tax will become available only after successful launch, i.e. about 5 - 8 years after having started development of the product, this long time period makes it almost impossible to connect any profit to the effects of a QbD driven development any more. However, the decrease in CMC development costs, or reduced timelines for development or the number of launched products in correlation to the investments needed for QbD can be calculated. Also, comparing the contribution margins of the products on the market with the investments for QbD during development might be a feasible approach, if products are already marketed.

⁷² Kotler; Principles of Marketing; appendix 2: calculation of ROI