Academic Press, 2001. — 586 p. — (Separation Science and Technology 3). — ISBN: 978-0-12-045555-3.
This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories.
Modern Pharmaceutical Analysis: An Overview
Combinatorial Chemistry and High-Throughput Screening in Drug Discovery and Development
Solid-State Analysis
Degradation and Impurity Analysis for Pharmaceutical Drug Candidates
Preformulation Studies
Solid Dosage-Form Analysis
Parenteral Dosage Forms
New Drug Delivery Systems
Compendial Testing
Method Development
Setting Up Specifications
Validation of Pharmaceutical Test Methods
Stability Studies
Analytical Methodology Transfer
Pharmaceutical Analysis Documentation
An Innovative Separation Platform: Electrophoretic Microchip Technology