QbD and Product Performance

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The QbD and Product Performance focus group (QbD & PP) is formed by individuals who are energized by the possibilities coming from integration of the QbD paradigm and biopharmaceutics, and its potential impact on enhancing drug product quality for the benefit of the consumer and the patient. We aim to fully integrate biopharmaceutics into QbD to achieve optimal drug product performance for the benefit of the patient.

The figure below depicts the nine priority areas for advancing integration of QbD and biopharmaceutics1 and their interrelationships, and places the patient's needs as the focus of drug development. All critical components are considered collectively for the patient benefit. This is reflected in the quality target product profile (QTPP), leading to the cascade of considerations for linking the process, product, and the patient throughout the product lifecycle.

To achieve this we rely on multidimensional collaborations to enrich our understanding of in vitro and in vivo factors that affect in vivo product performance, related to drug release, dissolution and delivery pattern leading to the desired clinical outcome. The focus group thrives as a collaboration forum for scientists of diverse backgrounds (such as biopharmaceutics, clinical pharmacology, chemistry, pharmaceutics, manufacturing sciences, statistics, and computational science) from across industry, academia and regulatory bodies. Our interests include exploring and advancing predictive tools and analytical, computational, and statistical approaches/methods for advancing, sharing, and leveraging knowledge for development and life-cycle management of drug products. QTPP-driven specifications and the biopharmaceutics risk assessment roadmap, are tangible measures of integration of QbD and biopharmaceutics (translational biopharmaceutics) –more detailed reading on these topics is available on our presentations and publications page.

To learn more about QbD & PP's goal. (PDF)

To learn more about QbD & PP's recent activities. (PDF)

Patient Benefit Diagram 

Reproduced with permission from AAPS. Figure 2 from: Selen A, Cruañes MT, Müllertz A, et al. Meeting Report: Applied Biopharmaceutics and Quality-by-Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit. AAPSJ. 2010; 12: 465-472. DOI: 10.1208/s12248-010-9206-0. All rights reserved.

1 - Meeting Report: Applied Biopharmaceutics and Quality by Design for dissolution/Release Specification Setting: Product Quality for Patient Benefit. The AAPS Journal, Vol. 12, No. 3, 465- 472, 2010

Section affiliations: FDD | MSE | RS  


AAPS Workshop on Co-Crystals: Latest Trends in Science and Regulatory Aspects
September 11, 2017
Hilton Washington DC/Rockville Hotel and Executive Meeting Center
Rockville, Md.

AAPS Workshop on In Vivo Predictive Drug Dissolution/Simulation
September 11–12, 2017
Hilton Washington DC/Rockville Hotel and Executive Meeting Center, Rockville, Md.

2017 AAPS Annual Meeting and Exposition
November 12–15, 2017
San Diego Convention Center, San Diego

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