Quality by Design (QbD) Paradigm: An Integrated Multivariate Approach to Transdermal Patch System Development
Prajwala S,
Sangeetha G,
Swamivelmanickam M
Abstract:: The International Council on Harmonization issued quality by design (QbD) guidelines, including Q8 (R2) pharmaceutical development, Q9 quality risk management, and Q10 pharmaceutical quality system, to ensure the quality of pharmaceutical products. For continual and consistent improvement of the quality of pharmaceutical drug products, QbD tools, such as risk assessment, design of experiment, and control strategy, are used, which can solve the narrow areas in product development. Transdermal patch systems (T… Show more
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