Specification of Drug Substances and Products: Development and Validation of Analytical Methods

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9780080983509: Specification of Drug Substances and Products: Development and Validation of Analytical Methods

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 productivity

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Product Description:

Title: Specification of Drug Substances and Products <>Binding: Hardcover <>Author: C M Riley <>Publisher: Elsevier Science & Technology

Review:

"...a valuable addition to a pharmaceutical scientists’ library....relevant and of interest to various “stake-holders in the drug development arena, including chemists, analysts, and programme managers. I can recommend it."--Organic Process Research & Development Journal, Sep-14

"Its main role is to explain how to meet the most recent International Conference on Harmonization guidelines for drug development. The book is organized to offer a critical and comprehensive account of the approaches used to identify the key determinants of quality production that affect the safety, effectiveness, and marketability of a drug."--ProtoView.com, April 2014

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Published by ELSEVIER SCIENCE TECHNOLOGY, United Kingdom (2013)
ISBN 10: 0080983502 ISBN 13: 9780080983509
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Book Description ELSEVIER SCIENCE TECHNOLOGY, United Kingdom, 2013. Hardback. Book Condition: New. 236 x 188 mm. Language: English . This book usually ship within 10-15 business days and we will endeavor to dispatch orders quicker than this where possible. Brand New Book. 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. Bookseller Inventory # EOD9780080983509

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Christopher M. Riley, Thomas W. Rosanske, Shelley R. Rabel Riley
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Book Description Elsevier Science & Technology. Hardback. Book Condition: new. BRAND NEW, Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Christopher M. Riley, Thomas W. Rosanske, Shelley R. Rabel Riley, 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 productivity. Bookseller Inventory # B9780080983509

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Published by ELSEVIER SCIENCE TECHNOLOGY, United Kingdom (2013)
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Book Description ELSEVIER SCIENCE TECHNOLOGY, United Kingdom, 2013. Hardback. Book Condition: New. 236 x 188 mm. Language: English . Brand New Book. 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. Bookseller Inventory # AAU9780080983509

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Riley, Christopher M.
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Book Description ELSEVIER SCIENCE TECHNOLOGY, United Kingdom, 2013. Hardback. Book Condition: New. 236 x 188 mm. Language: English . Brand New Book. 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. Bookseller Inventory # AAU9780080983509

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Book Description Elsevier Science & Technology, 2013. Book Condition: New. 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. Num Pages: 390 pages, Illustrated. BIC Classification: MMG; TDCW. Category: (P) Professional & Vocational. Dimension: 243 x 192 x 21. Weight in Grams: 970. . 2013. 1st Edition. Hardcover. . . . . . Bookseller Inventory # V9780080983509

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