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ISSN: 2574 -1241
ISSN: 2574 -1241
Received: October 25, 2017; Published: November 01, 2017
DOI: 10.26717/BJSTR.2017.01.000484
According to ICH Q8 guidelines, QBD is “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.”
Abbreviations: QbD: Quality By Design; ATP: Analytical Target Profile; HPLC: High Performance Liquid Chromatography; UV: Ultraviolent Rays; GC: Gas Chromatography; QCA: Critical Quality Attributes; MODR: Method Operational Design Region
Introduction| Elements of AQbD| Risk Assessment| MODR (Method Operational Design Region)| Method Control Strategy| Lifecycle Management| Conclusion|
International Association of Landscape Archaeology, Czech Glass Society, Czech Republic
Department of Chemistry, Semenov Institute of Chemical Physics, USSR Academy of Sciences, Moscow, Russia
Pharmaco-kinetics, dynamics and Drug Metabolism, Touro College of Pharmacy, USA
Professor of Nuclear Medicine, Faculty of Medicine and Surgery, University of Milan, Milan, Italy
Associate Professor at Department of Breast and Thyorid Surgey, Chongqing General Hospital, China
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