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Applications of QbD-based Software in Analytical Research and Development

Author(s):

Bikash Ranjan Jena*, Siva Prasad Panda, Kulandaivelu Umasankar, Suryakanta Swain, G.S.N Koteswara Rao, D. Damayanthi, Debashish Ghose and Debi Prasad Pradhan   Pages 1 - 13 ( 13 )

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 the 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 developments.

Methods:Traditional approach may fails to meet the intended purpose by trial and error procedure during the analytical research and development. However, in modern scientific technology equipped with highly advanced features associated software’s 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:Design of experiment assimilates 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’s and their applications in drug development and analytical research.

Keywords:

Auto-Chrome MDS, Minitab, Design Expert, Fusion Product Development, DoE wisdom, Elistat

Affiliation:

Southern Institute of Medical Sciences, College of Pharmacy, Guntur, Andhra Pradesh, Guntur-522001, KL College of Pharmacy, KL University (Deemed To Be University), Green Fields, Vaddeswaram, Guntur, Andhra Pradesh, KL College of Pharmacy, KL University (Deemed To Be University), Green Fields, Vaddeswaram, Guntur, Andhra Pradesh, Southern Institute of Medical Sciences, College of Pharmacy, Guntur, Andhra Pradesh, Guntur-522001, KL College of Pharmacy, KL University (Deemed To Be University), Green Fields, Vaddeswaram, Guntur, Andhra Pradesh, KL College of Pharmacy, KL University (Deemed To Be University), Green Fields, Vaddeswaram, Guntur, Andhra Pradesh, Department of Pharmaceutics, Roland Institute of Pharmaceutical Sciences, Berhampur-760 010, Odisha, GITAM Institute of Pharmacy, GITAM Deemed to be University, Visakhapatnam, Andhra Pradesh



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