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Specification of drug substances and products [recurso electrónico] : Development and Validation of Analytical Methods by Christopher M Riley; Thomas W Rosanske; Shelley R Rabel Riley; ProQuest (Firm) is a book available to read on EtoBox.

What is Specification of drug substances and products [recurso electrónico] : Development and Validation of Analytical Methods about?

<p><i>Specification of Drug Substances and Products: Development and Validation of Analytical Methods</i> 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.</p><br><br><ul><li>Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD)</li><li>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</li><li>Direct applicability to the day-to-da

Author

Christopher M Riley; Thomas W Rosanske; Shelley R Rabel Riley; ProQuest (Firm)

Publisher

Elsevier Science & Technology; Elsevier

Published

2013

Language

EN

ISBN

9780080983431

Subjects

Medical, Medicine