**3. Conclusion**

The ever-rising cost of novel dosage form development projects have not provided assurance of increased efficiency for delivering new drugs. In recent times, quality by design has shown great attention and is being spotlighted more than previously among pharmaceutical producers. Although consideration about its nomenclature and concepts remains indistinct, that may result in a lack of confidence

*Applications of Statistical Tools for Optimization and Development of Smart Drug Delivery… DOI: http://dx.doi.org/10.5772/intechopen.99632*

in applying the smart dosage form development. Knowing the disadvantages of quality by design on the one hand and in the other hand, getting a comprehensive understanding of quality by design can enable pharmaceutical manufacturers for employing the concepts of quality by design in utilization.

Robust manufacturing of smart pharmaceutical dosage forms, with their numerous complex formulations and the necessity for rigid similarity with the commercial formulations, essential for the understanding of CPPs and CMAs. The details collected from the development of novel dosage form overtime at laboratory scale provide the substructure for pivotal or pilot scale development. Statistical tools help not only in understanding and identifying CMAs and CPPs in dosage form development, but also in comprehension of the role and relationship between these in attaining a target quality. Although, the implementation of statistical approaches in the development of dosage form is strongly recommended. From a commercial point of view, at all stages of product development, the implementation of quality by design reduces the costs and accelerates the process of product commercialization.
