by Kim Huynh-Ba

Discover expert insights on pharmaceutical analysis with this definitive guide by Kim Huynh-Ba, authored by industry leaders with extensive experience. This authoritative resource provides a detailed exploration of pharmaceutical regulations, operational processes, and drug development best practices to ensure medicine quality and integrity, focusing on small molecular weight drug substances and products. It equips readers with the knowledge to establish GMP-compliant laboratories while adhering to Good Manufacturing Practices standards.

The book features concise, comprehensive chapters covering FDA and ICH regulations, analytical methodologies, control strategies, method development, validation, transfer, and electronic data documentation. It includes real-world case studies, dissolution testing for extended-release capsules, aerosols, and inhalers, stability programs, and Laboratory Information Management Systems (LIMS). Enhanced with tables, figures, calculations, and SOP templates, it supports daily laboratory operations and training.