Risk assessment

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Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm
Dénes Zalai, Christian Dietzsch and Christoph Herwig

PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 569-580; DOI: https://doi.org/10.5731/pdajpst.2013.00943
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The Reliability-Quality Relationship for Quality Systems and Quality Risk Management
H. Gregg Claycamp, Faiad Rahaman and Jason M. Urban

PDA Journal of Pharmaceutical Science and Technology November 2012, 66 (6) 512-517; DOI: https://doi.org/10.5731/pdajpst.2012.00888

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