Nitrosamines Demystified is a comprehensive, practical, and up-to-date guide designed for pharmaceutical professionals, students, and researchers navigating the evolving challenges of nitrosamine impurities.
This book integrates chemistry, toxicology, analytical science, and global regulations into a single structured reference offering clarity on complex topics such as CPCA categorization, CADRE modeling, NDSRI formation pathways, Ames testing, benchmark-dose modeling, and AI-driven prediction tools.
With seven detailed chapters, real word case studies, comparative regulatory tables, and appendices, the book provides both foundational understanding and actionable strategies aligned with EMA, US FDA, Health Canada, TGA, and ICH guidelines.
Whether you work in regulatory affairs, analytical R&D, formulation, API/process development, quality assurance, or pharmacovigilance, this book will help you navigate nitrosamine expectations confidently and scientifically.
Perfect for:
A must-read for anyone committed to pharmaceutical integrity and patient safety.
Autores populares
Unknown Author (247) Barrett Williams (162) ChatGPT ChatGPT (123) Сергей Каледин (110) Lyudmil Tsvetkov (97) Sharifa McFarlane (79) Rodrigo B Santos (64) Kingston Publishing (63) YouGuide (58) animarueaidezain (51) Kurt Bai (48) Clayton Louis Turnage (47) keieisyakentoushikaken (47) Nikolay Krechet (47) NK Gosine (44) e-aizamiraiseisei (40) SHIZUOKANOSORATETSU (40) Editora Europa (39) Valet WorkShop (36) Various (36)