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Specification of Drug Substances and Products - 9780080983509

Un libro in lingua di Riley Christopher M. (EDT) Rosanske Thomas W. (EDT) Riley Shelley R. Rabel (EDT) edito da Elsevier Science Ltd, 2013

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This book is a comprehensive and 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.

  • Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD)
  • Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authorities
  • Direct applicability to the day-to-day activities in drug development and the potential to increase productivity

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