By Valgenesis

Published in: Pharmaceutical OnLine

Published on: January 17, 2025

What Are the Benefits of AQbD Implementation? Analogous to QbD, a successful AQb implementation will focus on the definition of the operating ranges for the analytical method to meet the desired Analytical Target Profile, improving its robustness, and resulting in resource-efficient drug development. This approach will potentially minimize the out of specification results and consequently contribute to cost reduction. Moreover, the knowledge of the MODR increases regulatory flexibility and enables easier post-approval changes2, 3. The existence of clear guidelines is expected to encourage the use of more advanced analytical methods such as spectroscopy techniques, and to enable a robust quality oversight by drug manufacturers3

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