Description

Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use.

Key Features

  • Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it
  • Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations
  • Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Readership

Method development chemists, analytical chemists, organic chemists, pharmaceutical chemists, biochemists, medicinal chemists and licensing authorities.

Table of Contents

Overview (Satinder Ahuja); High Throughput Screening in Drug Discovery and Development (Ken Apple); Solid-State Analysis (Harry Brittain); Degradation Studies of Drug Candidates (Karen Alsante); Analytical Considerations for Genotoxic and Other Impurities (Scott Miller); Quality by Design (James Drennen); Preformulation Studies (tba); Process Analytical Technology (Christine Richardson); Solid Dosage-Form Analysis (Joe Etse); Parenteral Dosage Form Analysis (Greg Birrer); Analysis of Alternate Drug Delivery systems (Ron Smith); Method Development for Chiral Compounds (S. Ahuja); Method Development for Early Phase Drug Development (Kevin Bynum); Method Development for Late Phase Drug Development (Ilias Jimidar); Analysis of Biomolecules (Ilias Jimidar); Setting Up Specifications (Doug Raynie); Validation of Test Methods (Jonathan Crowther); Stability Evaluations (Jessica Cha); Transferring Analytical Methods (Stephen Scypinski); Pharmaceutical Analysis Documentation (H. Chokshi); Emerging Analytical Methodologies (Jim Lander)

Details

No. of pages:
598
Language:
English
Copyright:
© 2011
Published:
Imprint:
Academic Press
Electronic ISBN:
9780123759818
Print ISBN:
9780123756800

About the editors

Satinder Ahuja

Satinder Ahuja earned his PhD in analytical chemistry from the University of the Sciences, Philadelphia. He worked for Novartis Corp. in various leadership positions for over 25 years while simultaneously teaching and guiding research as an adjunct professor at Pace University for over 10 years. As president of Ahuja Consulting, he advises on quality issues relating to chemicals/pharmaceuticals and water. Dr. Ahuja has published numerous papers and more than eighteen books. Two of his latest books are entitled "Water Reclamation and Sustainability" (Elsevier) and Comprehensive "Water Quality and Purification" (Elsevier). Others include "Monitoring Water Quality: Pollution Assessment, Analysis, and Remediation" (Elsevier, 2013); "Novel Solutions to Water Pollution" (ACS Symposium Volume, 2013); "Handbook of Water Purity and Quality" (Elsevier, 2009); and "Arsenic Contamination of Water: Mechanism, Analysis, and Remediation" (Wiley, 2008). A member of the executive committee of Rivers of the World Foundation (ROW), Dr. Ahuja is an expert on improving water quality and has organized numerous global symposia on this topic (American Chemical Society, UNESCO, etc.) In 2013, he gave a lecture on the nexus of food, energy, and water and chaired a symposium on the subject for the American Chemical Society meeting in New Orleans.

Stephen Scypinski

Stephen Scypinski obtained his Ph.D. in analytical chemistry from Seton Hall University. He is director of analytical chemistry research and development department at R.W. Johnson Pharmaceutical Research Institute.