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Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition (Drugs and the Pharmaceutical Sciences)

Book Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition (Drugs and the Pharmaceutical Sciences)

Book details

- By: Steven W. Baertschi(Editor),Karen M. Alsante(Editor),Robert A. Reed(Editor)
- Language: English
- Format: PDF - Djvu
- Pages:624
- Publisher: CRC Press; 2 edition (July 27, 2011)
- Bestsellers rank: 4
- Category: New, Used & Rental Textbooks
*An electronic version of a printed book that can be read on a computer or handheld device designed specifically for this purpose.
Download ebook Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition (Drugs and the Pharmaceutical Sciences) by Steven W. Baertschi(Editor),Karen M. Alsante(Editor),Robert A. Reed(Editor) Language: English : pdf - djvu - online : eBooks for Free.
  

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The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years.

Key features include:

  • A renowned Editorial team and contributions from all major drug companies, reflecting a wealth of experience.
  • 10 new chapters, including Stress Testing and its relationship to the assessment of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations
  • Updated methodologies for predicting drug stability and degradation pathways
  • Best practice models to follow
  • An expanded Frequently Asked Questions section

This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).


Read online or download a free book: Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition (Drugs and the Pharmaceutical Sciences) PDF Books World offers free eBooks on fiction, non-fiction, academic, textbooks and children's categories for download in high quality PDF format.

  • By Chemiker on June 26, 2007

    Baertschi and his co-authors are the experts in the field of pharmaceutical stress testing. They cover the need for such work, the mechanisms of drug degradation, the practical aspects of performing the stress experiments, and the analysis of the products of the stress tests. No other book comes close.Anyone who needs to do this sort of work should buy this book. It is a fairly expensive book, but the information is very well work it.

  • By K HuynhBa on August 27, 2008

    This book should be in the library of any pharmaceutical scientist who involves with developing stability indicating methods or wishes to gain better understanding of drug degradation mechanism. It provides a wealth of resources and covers many aspects of stress testing. It includes theoretical as well as practical information. Steve Baertschi did an exceptional job bringing these topics together in one reference.For additional resource in the Stability Testing area, consider the following book:Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices

  • By Guest on September 14, 2010

    This book contians a wealth of inforrmation on stress testing. It is comprehensive and well written. Useful for anyone in the pharmaceutical industry interested in developing a thorough understanding of their product stability issues


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