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Drug Development Roadmap: From Lab Bench to Pharmacy Shelf is a comprehensive, real-world guide to the full lifecycle of pharmaceutical development-from early discovery to commercial launch. Written for scientists, regulatory professionals, formulation experts, and industry newcomers, this resource demystifies the drug development process with clarity and technical depth.
Drawing from more than two decades of global industry experience, author Mirela Gorjanu presents a step-by-step framework that spans target identification, preclinical studies, GMP manufacturing, analytical method development, clinical trials, regulatory submissions, and post-marketing surveillance.With Cardiovex-a fictitious case study drug-woven throughout, the book bridges theoretical concepts with practical execution, covering topics such as:
- Analytical method development (HPLC, LC-MS/MS, dissolution)
- GMP scale-up, packaging, and stability strategy
- Clinical trials, bioequivalence, and regulatory submission formats (CTD/eCTD)
- Risk management, pharmacovigilance, and lifecycle control
- Change control, serialization, and global pharmacy launch planning
Aligned with ICH, FDA, EMA, and WHO standards, this reference equips readers to navigate complex regulatory environments and build quality into every phase of development. Whether you're launching a new molecule or reformulating a generic, this roadmap delivers the insights and tools needed to accelerate innovation while ensuring compliance and patient safety.
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