- Series: Separation Science and Technology (Book 3)
- Hardcover: 566 pages
- Publisher: Academic Press; 1 edition (August 9, 2001)
- Language: English
- ISBN-10: 0120455552
- ISBN-13: 978-0120455553
- Product Dimensions: 7 x 1.2 x 10 inches
- Shipping Weight: 2.7 pounds (View shipping rates and policies)
- Amazon Best Sellers Rank: #4,302,116 in Books (See Top 100 in Books)
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Handbook of Modern Pharmaceutical Analysis, Volume 3 (Separation Science and Technology) 1st Edition
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In today's pharmaceutical industry, the analytical department plays a major role in the drug development process, providing accurate and precise data to support drug discovery, development, and market support. This handbook presents analytical research and development as a process-driven function assuring identity, safety, efficacy, purity, and quality of a product. Regulatory requirements and compliance are discussed as well as attempts to harmonize international regulatory authorities. Analytical techniques from the molecular to the bulk level, new drug discoveries, identification of impurities, various routes of administration, stability testing, and analytical documentation are all parts of the regulatory requirements during pre-approval inspections.
This book is well referenced and indexed. Each of the 16 chapters is written by experts and illustrated with figures, tables, and graphs. Anyone involved with new drug development, production, and control in the pharmaceutical industry would fine this title useful as well as graduate students and faculty in these areas. This would be a good acquisition for a graduate or research chemical or pharmaceutical library.
--E-Streams E-STREAMS Vol. 5, No. 6 - June 2002
On the whole this well written and thoroughly edited volume brings the reader up to date on a wide range of subjects pertaining to analytics in pharmaceutical industry.
--Alexander Nezlin, CTS Chemical Industries Ltd, Kiryat Malachi, Israel
From the Back Cover
This authoratative and practical handbook highlights the role of analytical R&D through its organization of chapters on a process-driven basis.
Includes coverage of:
* Regulatory requirements and compliance issues
* Material from the International Conference on Harmonization
* New drug discovery and optimization processes based on combinatorial chemistry coupled with high-througput screening
* Processes involved in developing successful formulations, including new delivery systems
* The nuts and bolts of pharmaceutical analysis that generally constitutes compendial testing, method developments, setting specifications, stability studies, and method validation
Additionally, the importance of excellent analytical documentation is discussed in regard to monitoring and ensuring the identity, purity, stability, and consistency of drug substance and dosage forms used during preclinical, clinical, and marketing phases in accordance with governing regulatory guidance and policies. New analytical platforms such as microfabricated electrophoresis devices are also reviewed and their applications to analysis of proteins, peptides, DNA, and small molecules, including chiral separations, are highlighted.
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