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Quality by Design and Analytical Quality by Design for Pharmaceutical Development

Authors: S. Furlanetto; S. Orlandini; B. Pasquini; R. Gotti; A. Guiraldelli;

Quality by Design and Analytical Quality by Design for Pharmaceutical Development

Abstract

Quality Target Product Profile (QTPP) is a concept that describes all the quality attributes (QA) of the product that can be optimized during the product development. Quality Control (QC) allows to assess the quality of the final product by means of the monitoring of the QAs and thus it is a key factor in pharmaceutical and biopharmaceutical development, since it assures safety and efficacy. Starting from the QTPP one or more analytical procedures (AP) have to be set up. Each AP has to be developed according to the quality attribute that has to be checked and this is defined in the Analytical Target Profile (ATP). The presentation will cover the application of Analytical Quality by Design (AQbD) principles and Design of Experiments (DoE) to AP development. The flowchart for AQbD adoption will be discussed, highlighting how DoE allows risk evaluation and mitigation. The presentation will point out the benefits of encouraging the use of DoE and other lifecyle tools to assist in achieving scientific goals, to have greater confidence in the data quality and decisions to be made based on the results obtained with the procedures.

Country
Italy
Related Organizations
Keywords

Analytical Procedure; Analytical Quality by Design; Pharmaceutical Analysis; Pharmaceutical Development; Quality by Design

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
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