Specification of Drug Substances and Products

Specification of Drug Substances and Products

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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 analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. 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 productivityamounts (e.g. in the ppm range) of highly colored materials can result in significant color changes. ... As mentioned earlier, qualitative visual color evaluations are generally a€œscoreda€ either based on the description itself or with reference to a standard sample or color chart. For stability testing usually a three- point scale is used and the sample color is rated as (0) unchanged, (1) slight acceptable change oranbsp;...

Title:Specification of Drug Substances and Products
Author: Christopher M. Riley, Thomas W. Rosanske, Shelley R. Rabel Riley
Publisher:Newnes - 2013-08-21

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