Handbook of Modern Pharmaceutical Analysis: Volume 10

ISBN-13: 9780123756800 / Angielski / Twarda / 2010 / 598 str.

Satinder Ahuja

Opis

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.

• 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

Spis treści

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)

O autorze

Satinder Ahuja is a leading expert on water quality improvement. He earned his PhD in analytical chemistry from the University of the Sciences in Philadelphia. He worked for Novartis Corp. in various leadership positions for over 25 years and taught as an adjunct professor at Pace University for over 10 years. As president of Ahuja Consulting, he advises on water quality issues relating to chemicals and pharmaceuticals. A member of the executive committee of the Rivers of the World Foundation (ROW), Dr. Ahuja has organized numerous global symposia on improving water quality, including presentations for the American Chemical Society and UNESCO. Dr. Ahuja has published numerous papers and more than 25 books. His latest books are Contaminants in Our Water (ACS, 2020); Evaluating Water Quality to Prevent Future Disasters (Elsevier, 2019); Advances in Water Purification Techniques (Elsevier, 2019); and Chemistry and Water (Elsevier, 2017). 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.