Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and current changes in the field. The work integrates strategy, case studies, methodologies, and implications of new regulations, providing the point of use.

* Treats pharmaceutical analysis (PA) as an integral part of the drug development process.
* Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations.
* LC-MS, LC-NMR, and LC-NMR-MS are detailed features and structures, as well as high-tech methodologies and technologies from "lab-on-a-chip".

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)