Increasingly stringent safety and efficacy standards, combined with the business challenges of rising development costs and greater frequencies of failure, put pressure on the pharmaceutical industry to improve the quality of drug candidates nominated for development.  By leveraging product design spaces created in pharmaceutical development, QbD in pre-clinical pharmacology provides a means for successfully addressing the safety and efficacy of drug candidates: with more certainty and at lower cost.

Productivity and efficiency receive little emphasis in pharmaceutical product manufacturing.  Nearly 25% of pharmaceutical industry expenses are incurred in product manufacturing, where waste can be as high as 50%.  QbD is a best practice strategy, well suited for improving overall plant performance, reducing costs, and assuring regulatory compliance.