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
reclinical 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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