Applications of QbD-based Software’s in Analytical Research and Development

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.

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.

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.

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.

The present review, critically discussed about the various QbD based multivariate software

and their applications in drug development and analytical research.