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Analytical Quality by Design with the Lifecycle Approach: A Modern Epitome for Analytical Method Development Cover

Analytical Quality by Design with the Lifecycle Approach: A Modern Epitome for Analytical Method Development

Open Access
|Jul 2019

Abstract

Quality by Design is the methodical method to development concept that starts with the predefined objects. The method put emphasis on the process of development of a product, the control process, which is built on risk management and comprehensive knowledge of science. The concept of QbD applied to analytical method development is known now as AQbD (Analytical Quality by Design). Comprehension of the Analytical Target Profile (ATP) and the risk assessment for the variables that can have an impact on the productivity of the developed analytical method can be the main principles of the AQbD. Inside the method operable design region (MODR), the AQbD permits the movements of the analytical methods. This paper has been produced to discuss various views of analytical scientists, the comparison with conventional methods, and the phases of the analytical techniques.

DOI: https://doi.org/10.2478/amma-2019-0010 | Journal eISSN: 2668-7763 | Journal ISSN: 2668-7755
Language: English
Page range: 37 - 44
Submitted on: Feb 4, 2019
Accepted on: May 23, 2019
Published on: Jul 4, 2019
Published by: University of Medicine, Pharmacy, Science and Technology of Targu Mures
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year

© 2019 Maher Abdulrazzaq Alhakeem, Mihaela Violeta Ghica, Cristina Dinu Pîrvu, Valentina Anuța, Lăcrămioara Popa, published by University of Medicine, Pharmacy, Science and Technology of Targu Mures
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.