TY - BOOK AU - Swartz,Michael AU - Krull,Ira S. TI - Analytical method development and validation SN - 9780824701154 U1 - 543.0894 PY - 2017/// CY - New York PB - M. Dekker KW - Pharmaceutical chemistry N1 - Includes bibliographical references N2 - "This concise guide delineates specific approaches to the successful development, optimization, and validation of high-quality HPLC-based analytical methods - demonstrating how these steps can be integrated into a formal process reflecting present United States Pharmacopeia (USP) regulations and International Conference on Harmonization (ICH) contributions." "Supplemented with an up-to-date bibliography, tables, and drawings, this convenient handbook is useful for analytical chemists and biochemists, pharmaceutical development chemists, pharmacologists, pharmacokineticists, laboratory and validation managers, and graduate-level students in these disciplines."--Jacket ER -