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Driving QbD as a quality standard in drug development

European Pharmaceutical Review

A paper published in the European Journal of Pharmaceutics and Biopharmaceutics has reviewed the current application status of Quality by Design (QbD) within the framework of the ICH guidelines (ICH Q8(R2) – Q14 and ICH Q2(R2)). The team examined the European Public Assessment Report (EPAR) for the QbD approach.

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QbD for Small-Molecule Continuous Process Development

PharmaTech

Continuous manufacturing and a quality-by-design development approach are a natural fit.

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The role of GAMP 5, data integrity and QbD in pharmaceutical quality assurance

European Pharmaceutical Review

Researchers have described the impact of data integrity, GAMP 5 and quality by design (QbD) principles on pharmaceutical quality assurance (QA) , highlighting the importance of data integrity through various case studies. Data integrity guarantees the reliability of data collected throughout various stages of drug development.”

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From Powder to Particles - Inhalation Particle Engineering With Jet Milling

PharmaTech

However, successful implementation of jet milling requires a robust Quality by Design (QbD) approach that ensures the critical quality attributes of the micronized particles are maintained throughout the process development. It will highlight the significance of implementing a QbD approach, and its benefits in process development.

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Formulation In-Depth Focus 2023

European Pharmaceutical Review

Exploring the complex pathway of paediatric drug development The formulation development of paediatric medications poses unique challenges compared to that of adult medications.

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Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle

Quality Matters

Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Practising QbD in biosimilar product development.