Specification of drug substances and products : development and validation of analytical methods / edited by Christopher M. Riley, Riley and Rabel Consulting Services, Maryville, MO, USA, Thomas W. Rosanske, T.W. Rosanske Consulting, Overland Park, KS, USA, Shelley R, Rabel Riley, Department of Natural Sciences, Northwest Missouri State University, Maryville, MO, USA ; Riley and Rabel Consulting Services, Maryville, MO, USA.

Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of a...

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