Description
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.
Table of Contents
Modern Pharmaceutical Analysis: An Overview (S. AHUJA)Combinatorial Chemistry and High-Throughput Screening in Drug Discovery and Development (KEN APPELL, JOHN J. BALDWIN, AND WILLIAM J. EGAN)Solid-State Analysis (HARRY G. BRITTAIN)Degradation and Impurity Analysis for Pharmaceutical Drug Candidates (KAREN M. ALSANTE, ROBERT C. FRIEDMANN, TODD D. HATAJIK, LINDA L. LOHR,THOMAS R. SHARP, KIMBERLY D. SNYDER, AND EDWARD J. SZCZESNY)Preformulation Studies (EDWARD LAU (deceased))Solid Dosage-Form Analysis (PHILIP J. PALERMO)Parenteral Dosage Forms (GREGORY A. BIRRER, SATYA S. MURTHY, AND JIE LIU)New Drug Delivery Systems (DAVID C. PANG)Compendial Testing (CHRISTINE F. RICHARDSON)Method Development (HENRIK T. RASMUSSEN)Setting Up Specifications (IAN E. DAVIDSON)Validation of Pharmaceutical Test Methods (JONATHAN B. CROWTHER)Stability Studies (JESSICA CHA, JOSEPH S. RANWEILER, PHILIP A. LANE)Analytical Methodology Transfer (STEPHEN SCYPINSKI)Pharmaceutical Analysis Documentation (HITESH CHOKSHI AND KATHLEEN SCHOSTACK)An Innovative Separation Platform: Electrophoretic Microchip Technology (LIAN JI JIN, JEROME FERRANCE, ZHILI HUANG, AND JAMES P. LANDERS)Index
