Handbook of Modern Pharmaceutical Analysis
Kurzbeschreibung Modern pharmaceutical analysis entails much more than the analysis of pharmaceuticals. This authoritative and practical handbook fills the need for a book that is current with respect to the philosophy of analytical chemistry support for drug discovery, development, and post-market support. Handbook of Modern Pharmaceutical Analysis highlights the role of analytical R&D through its organization of chapters on a 'process-driven' basis.
Includes coverage of: Regulatory requirements and compliance issues Material from the International Conference on Harmonization (ICH) New drug discovery and optimization processes based on combinatorial chemistry coupled with high-throughput screening Processes involved in developing successful formulations, including new delivery systems The nuts and bolts of pharmaceutical analysis that generally constitutes compendial testing, method development, setting specifications, stability studies and method validation
Additionally, the importance of excellent analytical documentation is discussed in regard to monitoring and ensuring the identity, purity, stability, and consistency of drug substance and dosage forms used during preclinical, clinical, and marketing phases in accordance with governing regulatory guidance and policies. New analytical platforms such as microfabricated electrophoresis devices are also reviewed and their applications to analysis of proteins, peptides, DNA, and small molecules, including chiral separations, are highlighted.
Synopsis This text describes the role modern pharmaceutical analysis plays in the development of new drugs. It discusses the techniques of discovering new drugs and developing convential and new dosage forms, how analytical methods are developed and selected for assuring the quality of drug products, and the successful transfer of technology development for a new drug product and its dependence on analytical methodology support.