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Extractables and Leachables in Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices: Characterization and Risk Assessment
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- Provides a comprehensive overview of extractables and leachables in drug products, packaging, manufacturing, and delivery systems, and medical devices.
- Discusses the characterization and risk assessment of extractables and leachables, including analytical methods, regulatory considerations, and safety thresholds.
- Covers the latest advances in extractables and leachables testing, including high-throughput screening and mass spectrometry techniques.
- Includes case studies and examples of how extractables and leachables have impacted the safety and efficacy of drug products and medical devices.
- Written by a team of experts in the field of extractables and leachables, this book is an essential resource for scientists, engineers, and regulators involved in the development and manufacture of drug products and medical devices.
Condition: New original from publisher
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