2nd Edition. — Academic Press, 2011. — 582 p. — (Separation Science and Technology 10). — ISBN: 978-0-12-045555-3.
Handbook 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.
OverviewHigh Throughput Screening in Drug Discovery and Development
Solid-State Analysis
Degradation Studies of Drug Candidates
Analytical Considerations for Genotoxic and Other Impurities
Quality by Design
Preformulation Studies (tba); Process Analytical Technology
Solid Dosage-Form Analysis
Parenteral Dosage Form Analysis
Analysis of Alternate Drug Delivery systems
Method Development for Chiral Compounds
Method Development for Early Phase Drug Development
Method Development for Late Phase Drug Development
Analysis of Biomolecules
Setting Up Specifications
Validation of Test Methods
Stability Evaluations
Transferring Analytical Methods
Pharmaceutical Analysis Documentation
Emerging Analytical Methodologies