Examining the basic principles of quality by design (QbD) approach in analytical studies

Burcu Mesut; Cem Önal; Buket Aksu; Yıldız Özsoy

Examining the basic principles of quality by design (QbD) approach in analytical studies

Abstract

Although the first application of Quality by Design (QbD) concept started for product development studies, the number of studies regarding its application to analytical development has been increased recently. Basically, QbD strategy in both formulation development and analytic studies are identical logically and conceptually, but they have somedifferences in terms of its terminology and application. Essential terminology and approach differences in this concept are; the determination of the analytic target profile, critical method characteristics, critical process parameters, and the determination of the method study area. However, the risk evaluation method which is necessary for the appropriate application of quality by design is also an inseparable part of the analytical quality by design. Despite those terminological differences, developing a qualitybased method with the analytical design that contributes to research with an appropriately applied risk-based design quality approach and provides multiple advantages that will be noticed each and every time, will be useful both for researchers and authorities who investigate license documentation and changes. Therefore, the terminology which is used for analytic quality by design and appropriate risk evaluation approaches are explained in this study.

Keywords

References

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Details

Primary Language

English

Subjects

Pharmacology and Pharmaceutical Sciences, Health Care Administration

Journal Section

Review

Authors

Burcu Mesut This is me
0000-0003-2838-1688
Türkiye

Cem Önal This is me
0000-0002-5840-7386
Palestine

Buket Aksu This is me
0000-0001-7555-0603
Türkiye

Yıldız Özsoy ^* This is me
0000-0002-9110-3704
Türkiye

Publication Date

August 31, 2021

Submission Date

September 9, 2020

Acceptance Date

December 29, 2020

Published in Issue

Year 2021 Volume: 51 Number: 2

IZ

https://izlik.org/JA22JW84JF

Cite

RIS / Bibtex

APA

Mesut, B., Önal, C., Aksu, B., & Özsoy, Y. (2021). Examining the basic principles of quality by design (QbD) approach in analytical studies. İstanbul Journal of Pharmacy, 51(2), 272-276. https://izlik.org/JA22JW84JF

AMA

1.Mesut B, Önal C, Aksu B, Özsoy Y. Examining the basic principles of quality by design (QbD) approach in analytical studies. iujp. 2021;51(2):272-276. https://izlik.org/JA22JW84JF

Chicago

Mesut, Burcu, Cem Önal, Buket Aksu, and Yıldız Özsoy. 2021. “Examining the Basic Principles of Quality by Design (QbD) Approach in Analytical Studies”. İstanbul Journal of Pharmacy 51 (2): 272-76. https://izlik.org/JA22JW84JF.

EndNote

Mesut B, Önal C, Aksu B, Özsoy Y (August 1, 2021) Examining the basic principles of quality by design (QbD) approach in analytical studies. İstanbul Journal of Pharmacy 51 2 272–276.

IEEE

[1]B. Mesut, C. Önal, B. Aksu, and Y. Özsoy, “Examining the basic principles of quality by design (QbD) approach in analytical studies”, iujp, vol. 51, no. 2, pp. 272–276, Aug. 2021, [Online]. Available: https://izlik.org/JA22JW84JF

ISNAD

Mesut, Burcu - Önal, Cem - Aksu, Buket - Özsoy, Yıldız. “Examining the Basic Principles of Quality by Design (QbD) Approach in Analytical Studies”. İstanbul Journal of Pharmacy 51/2 (August 1, 2021): 272-276. https://izlik.org/JA22JW84JF.

JAMA

1.Mesut B, Önal C, Aksu B, Özsoy Y. Examining the basic principles of quality by design (QbD) approach in analytical studies. iujp. 2021;51:272–276.

MLA

Mesut, Burcu, et al. “Examining the Basic Principles of Quality by Design (QbD) Approach in Analytical Studies”. İstanbul Journal of Pharmacy, vol. 51, no. 2, Aug. 2021, pp. 272-6, https://izlik.org/JA22JW84JF.

Vancouver

1.Burcu Mesut, Cem Önal, Buket Aksu, Yıldız Özsoy. Examining the basic principles of quality by design (QbD) approach in analytical studies. iujp [Internet]. 2021 Aug. 1;51(2):272-6. Available from: https://izlik.org/JA22JW84JF