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Specification of Drug Substances and Products

Av Christopher M. Riley (red), Thomas W. Rosanske (red)
  • Innbundet

  • 2013

  • Engelsk

Development and Validation of Analytical Methods

Presents a critical analysis of the requirements and approaches to setting specifications for the new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This title offers a guide to industry practices of analytical methodologies used in the specification of drug substances and products.

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