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Umbrella Reviews: Concepts, Methodological Frameworks, and Step-by-Step Implementation. [PDF]

open access: yesJ Evid Based Med
Liu C   +8 more
europepmc   +1 more source

ANALYTICAL QUALITY BY DESIGN ASSISTED METHOD DEVELOPMENT: A REVIEW

open access: yesInternational Journal of Biology, Pharmacy and Allied Sciences
openaire   +1 more source

Drilling into “Quality by Design” Approach for Analytical Methods

Critical Reviews in Analytical Chemistry, 2023
The need for consistency in analytical method development reinforces the dependence of pharmaceutical product development and manufacturing on robust analytical data. The Analytical Quality by Design (AQbD), akin to the product Quality by Design (QbD) endows a high degree of confidence to the method quality developed.
Lucas Chiarentin   +5 more
openaire   +2 more sources

Quality by Design Compliant Analytical Method Validation

Analytical Chemistry, 2011
The concept of quality by design (QbD) has recently been adopted for the development of pharmaceutical processes to ensure a predefined product quality. Focus on applying the QbD concept to analytical methods has increased as it is fully integrated within pharmaceutical processes and especially in the process control strategy. In addition, there is the
Rozet, Eric   +4 more
openaire   +2 more sources

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