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
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)
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