Extractables and Leachables: Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices
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"This book addresses the safety aspects of compatibility for drugs and their delivery devices and containers -- dealing with issues such as how the leachables impact safety of a therapeutic product and, more importantly, how one ascertains the magnitude of the impact. Although essential tenets and principles are relevant and useful today as 10 years ago, the E&L landscape has changed dramatically. In the book, the author covers new and forthcoming regulations and best practices, economic need to quickly develop and ...
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"This book addresses the safety aspects of compatibility for drugs and their delivery devices and containers -- dealing with issues such as how the leachables impact safety of a therapeutic product and, more importantly, how one ascertains the magnitude of the impact. Although essential tenets and principles are relevant and useful today as 10 years ago, the E&L landscape has changed dramatically. In the book, the author covers new and forthcoming regulations and best practices, economic need to quickly develop and commercialize safe and affordable clinical therapies, and looking at the diversity of products / materials / and applications on an individual or case basis rather than in general terms"--
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