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Green Fox Media LLC
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Item specifics

Condition
Very good: A book that does not look new and has been read but is in excellent condition. No obvious ...
ISBN
9780080983509

About this product

Product Identifiers

Publisher
Elsevier
ISBN-10
0080983502
ISBN-13
9780080983509
eBay Product ID (ePID)
159903301

Product Key Features

Number of Pages
390 Pages
Publication Name
Specification of Drug Substances and Products : Development and Validation of Analytical Methods
Language
English
Publication Year
2013
Subject
Chemistry / Analytic, Pharmacology, Chemistry / Organic, Chemistry / General
Type
Textbook
Author
Thomas W. Rosanske
Subject Area
Science, Medical
Format
Hardcover

Dimensions

Item Length
9.2 in
Item Width
7.5 in

Additional Product Features

Edition Number
2
Intended Audience
Scholarly & Professional
LCCN
2013-444132
Reviews
"...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, "...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, "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
Dewey Edition
23
Illustrated
Yes
Dewey Decimal
615.19
Table Of Content
Part One: Basic Concepts and Definitions 1. Introduction 2. General Principles and Regulatory Considerations: Specifications 3. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods 4. General Principles and Regulatory Considerations: Method Validation Part Two: Universal Tests 5. Description and Identification 6. Assay, and Impurities 7. Residual Solvents 8. Inorganic Impurities (Heavy Metals) Part Three: Specific Tests: Drug Substances 9. Solid-State Characterization 10. Chiral Methods 11. Water Determination Part Four: Specific Tests: Drug Products 12. Dissolution and Disintegration 13. Extractables and Leachables 14. Potency Assays for Biomolecules 15. Host Cell Protein Assays Part Five: Pharmacopeial Methods 16. Pharmacopeial Methods and Tests Part Six: Microbial Methods 17. Sterile and Non-Sterile Products Part Seven: Biological Fluids 18. Biological Fluids
Synopsis
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., 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
LC Classification Number
RS189

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