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Descrição do livro

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:

  • Regulatory affairs professionals
  • Analytical chemists
  • Formulation & process scientists
  • QA/QC specialists
  • Academics and trainees
  • Anyone preparing for regulatory submissions or audits
A must-read for anyone committed to pharmaceutical integrity and patient safety.

Número de páginas :377
Encadernação Nitrosamines Demystified: (Science, Regulation & Solutions) (English Edition):Kindle
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