Abstract

Optimization is an important step in the process of drug delivery design and development. Previously OFAT (one factor at a time) approach was used for optimization; however it is becoming an age old process. Now-a-days, pharmaceutical industries are opting for QbD (quality by design approach) which has become a coercion. However, on understanding the regulatory perspectives of pharmaceutical development, it is seen that QbD is benediction rather than a coercion. QbD reduces the variability through rational and systemic optimization. Maximum number of information can be obtained using minimum number of studies and it ensures the quality of the product.
With drug discovery being a cost-extensive program, pharmaceutical industries are more focussed on generic product development. Implementation of QbD not only ensures the quality of the product in minimum time and money but also reduces the post-approval submission load. In fact, many regulatory agencies across the world including US FDA has made implementation of QbD, a mandate requirement to develop all generic formulations. The presentation will focus on the various techniques and principles of QbD so that it is easier for the user to understand and implement.