Handbook of Modern Pharmaceutical Analysis Volume 10 2nd Edition by Satinder Ahuja, Stephen Scypinski ISBN 0123756804 9780123759818

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Product details:

ISBN 10: 0123756804

ISBN 13: 9780123759818

Author:  Satinder Ahuja, Stephen Scypinski 

Handbook of Modern Pharmaceutical Analysis (Volume 10) 2nd Edition : Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today’s laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use.

• Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it
• Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations
• Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from “lab-on-a-chip” to LC-MS, LC-NMR, and LC-NMR-MS

 

Handbook of Modern Pharmaceutical Analysis (Volume 10) 2nd Edition Table of contents:

• Chapter 1: Overview of modern pharmaceutical analysis
• Chapter 2: Characterization of pharmaceutical compounds in the solid state
• Chapter 3: Degradation and impurity analysis for pharmaceutical drug candidates
• Chapter 4: Analytical considerations for genotoxic and other impurities
• Chapter 5: Quality by design and the importance of PAT in QbD
• Chapter 6: Novel dosage form analysis
• Chapter 7: Method development for pharmaceutical chiral chromatography
• Chapter 8: Characterization and analysis of biopharmaceutical proteins
• Chapter 9: Preformulation and early phase method development
• Chapter 10: In-process control testing
• Chapter 11: Validation of analytical test methods
• Chapter 12: Stability studies
• Chapter 13: Analytical methodology transfer
• Chapter 14: Pharmaceutical analysis documentation

 

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