This compilation of 16 papers considers various aspects of pharmaceutical analysis as it relates to new drug development, production, control, and regulation. The book begins with methods for solid state analysis, degradation and impurity analysis, preformulation studies, and solid dosage form analysis, such as spectroscopy, chromatography, x-ray diffraction, and differential scanning calorimetry. Later papers discuss new drug delivery systems, compendial testing, method development, setting specifications, method validation, proper documentation, and microfabricated electrophoresis devices. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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.
No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.
