Introduction to Quality by Design (QbD)

From Theory to Practice

N. K. Jain (Hrsg.), Neha Bajwa (Hrsg.)

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Springer Nature Singapore img Link Publisher

Naturwissenschaften, Medizin, Informatik, Technik / Biochemie, Biophysik

Beschreibung

This book offers a comprehensive exploration of the Quality by Design (QbD) methodology, guiding readers from theory to practical application with accessible examples. It equips readers with both foundational and advanced knowledge, emphasizing the critical parameters necessary for designing pharmaceutical products that meet the highest quality standards. The book goes beyond theory to demonstrate how to effectively implement QbD principles in various aspects of pharmaceutical research and development, including analytical methods, formulation, and packaging processes. Through a step-by-step approach, it prepares researchers in pharmaceutical sciences, as well as professionals in the pharmaceutical and healthcare industries (including suppliers), to successfully integrate QbD into their work.

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Schlagwörter

Pharmaceutical Research, Analytical QbD, Target Product Profile (TPP), Critical Material Attributes (CMA), Formulation QbD, Critical Quality Attributes (CQA), Quality by Design (QbD),, Critical Process Parameter (CPP), Target Product Quality Profile (TPQP)