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Free Download FROM DISCOVERY TO APPROVAL: A ROADMAP FOR DRUG ANALYSIS AND VALIDATION (Pharmaceutical Industry Book ) by Mirela Gorjanu
English | June 6, 2025 | ISBN: N/A | ASIN: B0FCCTZSWQ | 71 pages | EPUB | 0.36 Mb
From Discovery to Approval: A Roadmap for Drug Analysis and Validation is a comprehensive and practical guide for navigating the complex landscape of pharmaceutical analytics and regulatory compliance. This book serves as a step-by-step resource for scientists, analysts, regulatory professionals, and students seeking a thorough understanding of how drugs are developed, analyzed, and validated from lab bench to regulatory approval.
Spanning the entire drug development lifecycle, the guide focuses on key topics such as:Preclinical and clinical analytical strategyMethod development and validation (HPLC, LC-MS/MS, spectroscopy)Bioanalytical testing and stability studiesRegulatory frameworks: ICH, FDA, EMA, and WHO guidelinesGMP/GLP standards in pharmaceutical analysisCommon challenges in assay development, impurity profiling, and data integrityEach chapter offers detailed workflows, real-world examples, and checklists to ensure analytical robustness and compliance with international standards. Whether you're developing a new molecule or validating a bioanalytical method for clinical trials, this book empowers you with the tools and insight to succeed.
Your roadmap to mastering the science, strategy, and standards behind pharmaceutical analysis.
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