Handbook of Modern Pharmaceutical Analysis

Edited by

  • Satinder Ahuja, Ahuja Consulting, Calabash, NC, USA
  • Stephen Scypinski, R.W. Johnson Pharmaceutical Research Institute, Raritan, New Jersey, U.S.A.

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.
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Pharmaceutical scientists in industry, government, and academia.


Book information

  • Published: July 2001
  • ISBN: 978-0-12-045555-3


oday's pharmaceutical industry, the analytical department plays a major role in the drug development process, providing accurate and precise data to support drug discovery, development, and market support. This handbook presents analytical research and development as a process-driven function assuring identity, safety, efficacy, purity, and quality of a product. Regulatory requirements and compliance are discussed as well as attempts to harmonize international regulatory authorities. Analytical techniques from the molecular to the bulk level, new drug discoveries, identification of impurities, various routes of administration, stability testing, and analytical documentation are all parts of the regulatory requirements during pre-approval inspections. This book is well referenced and indexed. Each of the 16 chapters is written by experts and illustrated with figures, tables, and graphs. Anyone involved with new drug development, production, and control in the pharmaceutical industry would fine this title useful as well as graduate students and faculty in these areas. This would be a good acquisition for a graduate or research chemical or pharmaceutical library.
--E-Streams E-STREAMS Vol. 5, No. 6 - June 2002

On the whole this well written and thoroughly edited volume brings the reader up to date on a wide range of subjects pertaining to analytics in pharmaceutical industry.
--Alexander Nezlin, CTS Chemical Industries Ltd, Kiryat Malachi, Israel

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