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Pharma Bioanalytical Lab: A Practical Guide
Paperback
Series: Pharmaceutical Industry, Book 5
Publisher: Independently Published
Published: May 21 2025
Pages: 102
Weight: 0.32
Height: 0.21 Width: 6.00 Depth: 9.00
Language: English
by Mirela Gorjanu
In the high-stake world of pharmaceutical development, data integrity isn't optional; it's critical. Pharma Bioanalytical Lab: A Practical Guide is the definitive handbook for scientists, analysts, and quality professionals working in regulated bioanalytical environments. Whether you're managing GLP-compliant studies, preparing for regulatory audits, or validating LC-MS/MS methods, this guide delivers practical, real-world strategies to ensure accuracy, compliance, and efficiency.
- Step-by-step instructions for method development, validation, and documentation
- Templates and SOP outlines for daily lab operations
- Tools for deviation management, CAPAs, and analytical risk assessments
- Regulatory insights from FDA, EMA, WHO, and ICH M10 standards
- Visual aids, glossary terms, and case studies that simplify complex concepts
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