Handbook of Modern Pharmaceutical Analysis

Satinder Ahuja, Stephen Scypinski

• Publisher: Academic Press
• Year: 2010
• Edition: 2
• eBook ISBN:
  9780123759818
• Topic: Medicine
• Subtopic: Pharmacology

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

Table of contents

• Cover image
• Title page
• Table of Contents
• Series Editors
• Copyright
• Preface
• Contributors
• 1 Overview of Modern Pharmaceutical Analysis
• 2 Characterization of Pharmaceutical Compounds in the Solid State
• 3 Degradation and Impurity Analysis for Pharmaceutical Drug Candidates
• 4 Analytical Considerations for Genotoxic and Other Impurities
• 5 Quality by Design and the Importance of PAT in QbD
• 6 Novel Dosage Form Analysis
• 7 Method Development for Pharmaceutical Chiral Chromatography
• 8 Characterization and Analysis of Biopharmaceutical Proteins
• 9 Preformulation and early phase method development
• 10 In-Process Control Testing
• 11 Validation of Analytical Test Methods
• 12 Stability Studies
• 13 Analytical Methodology Transfer
• 14 Pharmaceutical Analysis Documentation
• Subject Index