Abstract

Background: Quality by design-based software’s in analytical research and development normally encompasses multiple objectives. For decades, this task has been attempted through trial and error, supplemented with the previous experience, knowledge, and wisdom of analytical researchers.

Objective: The study analyzes the current QbD-assisted software’s, such as design-experts, minitab, fusion product development, etc., and its broad implementations in an analytical research and development.

Methods: The traditional approach may fails to meet the intended purpose by trial and error procedure during analytical research and development. However, modern scientific technology is equipped with highly advanced features associated with the software of the QbD paradigm. The impact and interactions between the critical process variables and critical method attributes such as resolution, tailing, etc. can be well understood by the screening, optimization, and robustness studies based on the principles of experimental design.

Results: The design of experiments assimilate statistical multi-variate analysis instead of one factor at a time approach. This also provides a prominent, most reliable quality output, which is also essential for getting highly robust method as well as to obtain homogenous product development.

Conclusion: The present review, critically discussed about the various QbD based multivariate software and their applications in drug development and analytical research.

Keywords: Auto-chrome MDS, minitab, design expert, fusion product development, DoE wisdom, ellistat.

Graphical Abstract